Method and apparatus for intra-aortic substance delivery to a branch vessel

ABSTRACT

A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bi-laterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly includes two injection members, each having an injection port that couples to a source of fluid agent externally of the patient. The injection ports may be positioned with an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries. A flow isolation assembly may isolate flow of the injected agent within the outer region and into the renals. The injection members are delivered to the location in a first radially collapsed condition, and bifurcate across the aorta to inject into the spaced renal ostia. A delivery catheter for upstream interventions is used as a chassis to deliver a bilateral local renal injection assembly to the location within the abdominal aorta.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of PCT Patent Application No.PCT/US03/299995 (Attorney Docket No. 022352-001100PC), filed Sep. 22,2003, which claims priority from U.S. Provisional Application Ser. Nos.:60/412,343 (Attorney Docket No. 022352-000700US), filed on Sep. 20,2002; 60/412,476 (Attorney Docket No. 022352-000800US), filed on Sep.20, 2002; 60/479,329 (Attorney Docket No. 022352-000900US), filed onJun. 17, 2003; and 60/502,389 (Attorney Docket No. 022352-00110US),filed on Sep. 13, 2003. The full disclosure of each of the foregoingapplications is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention pertains generally to medical device systems and methodsfor intra aortic fluid delivery into regions of the body. Morespecifically, it is related to intra aortic renal fluid delivery systemsand methods.

2. Description of Related Art

Many different medical device systems and methods have been previouslydisclosed for locally delivering fluids or other agents into variousbody regions, including body lumens such as vessels, or other bodyspaces such as organs or heart chambers. Local “fluid” delivery systemsmay include drugs or other agents, or may even include locallydelivering the body's own fluids, such as artificially enhanced bloodtransport (e.g. either entirely within the body such as directing orshunting blood from one place to another, or in extracorporeal modessuch as via external blood pumps etc.). Local “agent” delivery systemsare herein generally intended to relate to introduction of a foreigncomposition as an agent into the body, which may include drug or otheruseful or active agent, and may be in a fluid form or other form such asgels, solids, powders, gases, etc. It is to be understood that referenceto only one of the terms fluid, drug, or agent with respect to localdelivery descriptions may be made variously in this disclosure forillustrative purposes, but is not generally intended to be exclusive oromissive of the others; they are to be considered interchangeable whereappropriate according to one of ordinary skill unless specificallydescribed to be otherwise.

In general, local agent delivery systems and methods are often used forthe benefit of achieving relatively high, localized concentrations ofagent where injected within the body in order to maximize the intendedeffects there and while minimizing unintended peripheral effects of theagent elsewhere in the body. Where a particular dose of a locallydelivered agent may be efficacious for an intended local effect, thesame dose systemically delivered would be substantially dilutedthroughout the body before reaching the same location. The agent'sintended local effect is equally diluted and efficacy is compromised.Thus systemic agent delivery requires higher dosing to achieve therequired localized dose for efficacy, often resulting in compromisedsafety due to for example systemic reactions or side effects of theagent as it is delivered and processed elsewhere throughout the bodyother than at the intended target.

Various diagnostic systems and procedures have been developed usinglocal delivery of dye (e.g. radiopaque “contrast” agent) or otherdiagnostic agents, wherein an external monitoring system is able togather important physiological information based upon the diagnosticagent's movement or assimilation in the body at the location of deliveryand/or at other locations affected by the delivery site. Angiography isone such practice using a hollow, tubular angiography catheter forlocally injecting radiopaque dye into a blood chamber or vessel, such asfor example coronary arteries in the case of coronary angiography, or ina ventricle in the case of cardiac ventriculography.

Other systems and methods have been disclosed for locally deliveringtherapeutic agent into a particular body tissue within a patient via abody lumen. For example, angiographic catheters of the type justdescribed above, and other similar tubular delivery catheters, have alsobeen disclosed for use in locally injecting treatment agents throughtheir delivery lumens into such body spaces within the body. Moredetailed examples of this type include local delivery of thrombolyticdrugs such as TPA™, heparin, cumadin, or urokinase into areas ofexisting clot or thrombogenic implants or vascular injury. In addition,various balloon catheter systems have also been disclosed for localadministration of therapeutic agents into target body lumens or spaces,and in particular associated with blood vessels. More specificpreviously disclosed of this type include balloons with porous orperforated walls that elute drug agents through the balloon wall andinto surrounding tissue such as blood vessel walls. Yet further examplesfor localized delivery of therapeutic agents include various multipleballoon catheters that have spaced balloons that are inflated to engagea lumen or vessel wall in order to isolate the intermediate catheterregion from in-flow or out-flow across the balloons. According to theseexamples, a fluid agent delivery system is often coupled to thisintermediate region in order to fill the region with agent such as drugthat provides an intended effect at the isolated region between theballoons.

The diagnosis or treatment of many different types of medical conditionsassociated with various different systems, organs, and tissues, may alsobenefit from the ability to locally deliver fluids or agents in acontrolled manner. In particular, various conditions related to therenal system would benefit a great deal from an ability to locallydeliver of therapeutic, prophylactic, or diagnostic agents into therenal arteries.

Acute renal failure (“ARF”) is an abrupt decrease in the kidney'sability to excrete waste from a patient's blood. This change in kidneyfunction may be attributable to many causes. A traumatic event, such ashemorrhage, gastrointestinal fluid loss, or renal fluid loss withoutproper fluid replacement may cause the patient to go into ARF. Patientsmay also become vulnerable to ARF after receiving anesthesia, surgery,or a-adrenergic agonists because of related systemic or renalvasoconstriction. Additionally, systemic vasodilation caused byanaphylaxis, and anti-hypertensive drugs, sepsis or drug overdose mayalso cause ARF because the body's natural defense is to shut down, i.e.,vasoconstrict, non-essential organs such as the kidneys. Reduced cardiacoutput caused by cardiogenic shock, congestive heart failure,pericardial tamponade or massive pulmonary embolism creates an excess offluid in the body, which can exacerbate congestive heart failure. Forexample, a reduction in blood flow and blood pressure in the kidneys dueto reduced cardiac output can in turn result in the retention of excessfluid in the patient's body, leading, for example, to pulmonary andsystemic edema.

Previously known methods of treating ARF, or of treating acute renalinsufficiency associated with congestive heart failure (“CHF”), involveadministering drugs. Examples of such drugs that have been used for thispurpose include, without limitation: vasodilators, including for examplepapavarine, fenoldopam mesylate, calcium-channel blockers, atrialnatriuretic peptide (ANP), acetylcholine, nifedipine, nitroglycerine,nitroprusside, adenosine, dopamine, and theophylline; antioxidants, suchas for example acetylcysteine; and diuretics, such as for examplemannitol, or furosemide. However, many of these drugs, when administeredin systemic doses, have undesirable side effects. Additionally, many ofthese drugs would not be helpful in treating other causes of ARF. Whilea septic shock patient with profound systemic vasodilation often hasconcomitant severe renal vasoconstriction, administering vasodilators todilate the renal artery to a patient suffering from systemicvasodilation would compound the vasodilation system wide. In addition,for patients with severe CHF (e.g., those awaiting heart transplant),mechanical methods, such as hemodialysis or left ventricular assistdevices, may be implemented. Surgical device interventions, such ashemodialysis, however, generally have not been observed to be highlyefficacious for long-term management of CHF. Such interventions wouldalso not be appropriate for many patients with strong hearts sufferingfrom ARF.

The renal system in many patients may also suffer from a particularfragility, or otherwise general exposure, to potentially harmful effectsof other medical device interventions. For example, the kidneys as oneof the body's main blood filtering tools may suffer damage from exposedto high density radiopaque contrast dye, such as during coronary,cardiac, or neuro angiography procedures. One particularly harmfulcondition known as “radiocontrast nephropathy” or “RCN” is oftenobserved during such procedures, wherein an acute impairment of renalfunction follows exposure to such radiographic contrast materials,typically resulting in a rise in serum creatinine levels of more than25% above baseline, or an absolute rise of 0.5 mg/dl within 48 hours.Therefore, in addition to CHF, renal damage associated with RCN is alsoa frequently observed cause of ARF. In addition, the kidneys' functionis directly related to cardiac output and related blood pressure intothe renal system. These physiological parameters, as in the case of CHF,may also be significantly compromised during a surgical interventionsuch as an angioplasty, coronary artery bypass, valve repair orreplacement, or other cardiac interventional procedure. Therefore, thevarious drugs used to treat patients experiencing ARF associated withother conditions such as CHF have also been used to treat patientsafflicted with ARF as a result of RCN. Such drugs would also providesubstantial benefit for treating or preventing ARF associated withacutely compromised hemodynamics to the renal system, such as duringsurgical interventions.

There would be great advantage therefore from an ability to locallydeliver such drugs into the renal arteries, in particular when deliveredcontemporaneous with surgical interventions, and in particularcontemporaneous with radiocontrast dye delivery. However, many suchprocedures are done with medical device systems, such as using guidingcatheters or angiography catheters having outer dimensions typicallyranging between about 4 French to about 12 French, and ranging generallybetween about 6 French to about 8 French in the case of guide cathetersystems for delivering angioplasty or stent devices into the coronary orneurovascular arteries (e.g. carotid arteries). These devices also aremost typically delivered to their respective locations for use (e.g.coronary ostia) via a percutaneous, translumenal access in the femoralarteries and retrograde delivery upstream along the aorta past theregion of the renal artery ostia. A Seldinger access technique to thefemoral artery involves relatively controlled dilation of a puncturehole to minimize the size of the intruding window through the arterywall, and is a preferred method where the profiles of such deliverysystems are sufficiently small. Otherwise, for larger systems a“cut-down” technique is used involving a larger, surgically made accesswindow through the artery wall.

Accordingly, an intra aortic renal agent delivery system forcontemporaneous use with other retrogradedly delivered medical devicesystems, such as of the types just described above, would preferably beadapted to allow for such interventional device systems, in particularof the types and dimensions just described, to pass upstream across therenal artery ostia (a) while the agent is being delivered into the renalarteries, and (b) while allowing blood to flow downstream across therenal artery ostia, and (c) in an overall cooperating system that allowsfor Seldinger femoral artery access. Each one of these features (a),(b), or (c), or any sub-combination thereof, would provide significantvalue to patient treatment; an intra aortic renal delivery systemproviding for the combination of all three features is so much the morevaluable.

Notwithstanding the clear needs for and benefits that would be gainedfrom such intra aortic drug delivery into the renal system, the abilityto do so presents unique challenges as follows.

In one regard, the renal arteries extend from respective ostia along theabdominal aorta that are significantly spaced apart from each othercircumferentially around the relatively very large aorta. Often, theserenal artery ostia are also spaced from each other longitudinally alongthe aorta with relative superior and inferior locations. This presents aunique challenge to deliver drugs or other agents into the renal systemon the whole, which requires both kidneys to be fed through theseseparate respective arteries via their uniquely positioned andsubstantially spaced apart ostia. This becomes particularly importantwhere both kidneys may be equally at risk, or are equally compromised,during an invasive upstream procedure—or, of course, for any otherindication where both kidneys require renal drug delivery. Thus, anappropriate intra aortic delivery system for such indications wouldpreferably be adapted to feed multiple renal arteries perfusing bothkidneys.

In another regard, mere delivery of an agent into the natural,physiologic blood flow path of the aorta upstream of the kidneys mayprovide some beneficial, localized renal delivery versus other systemicdelivery methods, but various undesirable results still arise. Inparticular, the high flow aorta immediately washes much of the deliveredagent beyond the intended renal artery ostia. This reduces the amount ofagent actually perfusing the renal arteries with reduced efficacy, andthus also produces unwanted loss of the agent into other organs andtissues in the systemic circulation (with highest concentrationsdirectly flowing into downstream circulation).

In still a further regard, various known types of tubular local deliverycatheters, such as angiographic catheters, other “end-hole” catheters,or otherwise, may be positioned with their distal agent perfusion portslocated within the renal arteries themselves for delivering agentsthere, such as via a percutaneous translumenal procedure via the femoralarteries (or from other access points such as brachial arteries, etc.).However, such a technique may also provide less than completelydesirable results.

For example, such seating of the delivery catheter distal tip within arenal artery may be difficult to achieve from within the largediameter/high flow aorta, and may produce harmful intimal injury withinthe artery. Also, where multiple kidneys must be infused with agent,multiple renal arteries must be cannulated, either sequentially with asingle delivery device, or simultaneously with multiple devices. Thiscan become unnecessarily complicated and time consuming and furthercompound the risk of unwanted injury from the required cathetermanipulation. Moreover, multiple dye injections may be required in orderto locate the renal ostia for such catheter positioning, increasing therisks associated with contrast agents on kidney function (e.g. RCN)—thevery organ system to be protected by the agent delivery system in thefirst place. Still further, the renal arteries themselves, possiblyincluding their ostia, may have pre-existing conditions that eitherprevent the ability to provide the required catheter seating, or thatincrease the risks associated with such mechanical intrusion. Forexample, the artery wall may be diseased or stenotic, such as due toatherosclerotic plaque, clot, dissection, or other injury or condition.Finally, among other additional considerations, previous disclosureshave yet to describe an efficacious and safe system and method forpositioning these types of local agent delivery devices at the renalarteries through a common introducer or guide sheath shared withadditional medical devices used for upstream interventions, such asangiography or guide catheters. In particular, to do so concurrentlywith multiple delivery catheters for simultaneous infusion of multiplerenal arteries would further require a guide sheath of such significantdimensions that the preferred Seldinger vascular access technique wouldlikely not be available, instead requiring the less desirable “cut-down”technique.

In addition to the various needs for delivering agents into brancharteries described above, much benefit may also be gained from simplyenhancing blood perfusion into such branches, such as by increasing theblood pressure at their ostia. In particular, such enhancement wouldimprove a number of medical conditions related to insufficientphysiological perfusion into branch vessels, and in particular from anaorta and into its branch vessels such as the renal arteries.

Certain prior disclosures have provided surgical device assemblies andmethods intended to enhance blood delivery into branch arteriesextending from an aorta. For example, intra-aortic balloon pumps (IABPs)have been disclosed for use in diverting blood flow into certain brancharteries. One such technique involves placing an IABP in the abdominalaorta so that the balloon is situated slightly below (proximal to) thebranch arteries. The balloon is selectively inflated and deflated in acounterpulsation mode (by reference to the physiologic pressure cycle)so that increased pressure distal to the balloon directs a greaterportion of blood flow into principally the branch arteries in the regionof their ostia. However, the flow to lower extremities downstream fromsuch balloon system can be severely occluded during portions of thiscounterpulsing cycle. Moreover, such previously disclosed systemsgenerally lack the ability to deliver drug or agent to the brancharteries while allowing continuous and substantial downstream perfusionsufficient to prevent unwanted ischemia.

It is further noted that, despite the renal risks described in relationto radiocontrast dye delivery, and in particular RCN, in certaincircumstances delivery of such dye or other diagnostic agents isindicated specifically for diagnosing the renal arteries themselves. Forexample, diagnosis and treatment of renal stenosis, such as due toatherosclerosis or dissection, may require dye injection into a subjectrenal artery. In such circumstances, enhancing the localization of thedye into the renal arteries may also be desirable. In one regard,without such localization larger volumes of dye may be required, and thedye lost into the downstream aortic flow may still be additive toimpacting the kidney(s) as it circulates back there through the system.In another regard, an ability to locally deliver such dye into the renalartery from within the artery itself, such as by seating an angiographycatheter there, may also be hindered by the same stenotic conditionrequiring the dye injection in the first place (as introduced above).Still further, patients may have stent-grafts that may prevent deliverycatheter seating.

Notwithstanding the interest and advances toward delivering agents fortreatment or diagnosis of organs or tissues, the previously disclosedsystems and methods summarized immediately above generally lack theability to effectively deliver agents from within a main artery andlocally into substantially only branch arteries extending therefromwhile allowing the passage of substantial blood flow and/or othermedical devices through the main artery past the branches. This is inparticular the case with previously disclosed renal treatment anddiagnostic devices and methods, which do not adequately provide forlocal delivery of agents into the renal system from a location withinthe aorta while allowing substantial blood flow continuously downstreampast the renal ostia and/or while allowing distal medical deviceassemblies to be passed retrogradedly across the renal ostia forupstream use. Much benefit would be gained if agents, such as protectiveor therapeutic drugs or radiopaque contrast dye, could be delivered toone or both of the renal arteries in such a manner.

Several more recently disclosed advances have included local flowassemblies using tubular members of varied diameters that divide flowwithin an aorta adjacent to renal artery ostia into outer and inner flowpaths substantially perfusing the renal artery ostia and downstreamcirculation, respectively. Such disclosures further include deliveringfluid agent primarily into the outer flow path for substantiallylocalized delivery into the renal artery ostia. These disclosed systemsand methods represent exciting new developments toward localizeddiagnosis and treatment of pre-existing conditions associated withbranch vessels from main vessels in general, and with respect to renalarteries extending from abdominal aortas in particular.

However, such previously disclosed designs would still benefit fromfurther modifications and improvements in order to: maximize mixing of afluid agent within the entire circumference of the exterior flow pathsurrounding the tubular flow divider and perfusing multiple renal arteryostia; use the systems and methods for prophylaxis and protection of therenal system from harm, in particular during upstream interventionalprocedures; maximize the range of useful sizing for specific devices toaccommodate a wide range of anatomic dimensions between patients; andoptimize the construction, design, and inter-cooperation between systemcomponents for efficient, atraumatic use.

A need still exists for improved devices and methods for deliveringagents principally into the renal arteries of a patient from a locationwithin the patient's aorta adjacent the renal artery ostia along theaorta wall while at least a portion of aortic blood flow is allowed toperfuse downstream across the location of the renal artery ostia andinto the patient's lower extremities.

A need still exists for improved devices and methods for substantiallyisolating first and second portions of aortic blood flow at a locationwithin the aorta of a patient adjacent the renal artery ostia along theaorta wall, and directing the first portion into the renal arteries fromthe location within the aorta while allowing the second portion to flowacross the location and downstream of the renal artery ostia into thepatient's lower extremities. There is a further benefit and need forproviding passive blood flow along the isolated paths and withoutproviding active in-situ mechanical flow support to either or both ofthe first or second portions of aortic blood flow.

A need still exists for improved devices and methods for locallydelivering agents such as radiopaque dye or drugs into a renal arteryfrom a location within the aorta of a patient adjacent the renalartery's ostium along the aorta wall, and without requiring translumenalpositioning of an agent delivery device within the renal artery itselfor its ostium.

A need still exists for improved devices and methods for bilateraldelivery of fluids or agents such as radiopaque dye or drugssimultaneously into multiple renal arteries feeding both kidneys of apatient using a single delivery device and without requiringtranslumenal positioning of multiple agent delivery devices respectivelywithin the multiple renal arteries themselves.

A need still exists for improved devices and methods for delivery offluids or agents into the renal arteries of a patient from a locationwithin the patient's aorta adjacent the renal artery ostia along theaorta wall, and while allowing other treatment or diagnostic devices andsystems, such as angiographic or guiding catheter devices and relatedsystems, to be delivered across the location.

A need still exists for improved devices and methods for deliveringfluids or agents into the renal arteries from a location within theaorta of a patient adjacent to the renal artery ostia along the aortawall, and other than as a remedial measure to treat pre-existing renalconditions, and in particular for prophylaxis or diagnostic proceduresrelated to the kidneys.

A need still exists for improved devices and methods for delivery offluids or agents into the renal arteries of a patient in order to treat,protect, or diagnose the renal system adjunctive to performing othercontemporaneous medical procedures such as angiograms other translumenalprocedures upstream of the renal artery ostia.

A need still exists for improved devices and methods for delivering bothan intra aortic drug delivery system and at least one adjunctive distalinterventional device, such as an angiographic or guiding catheter,through a common delivery sheath.

A need also still exists for improved devices and methods for deliveringboth an intra aortic drug delivery system and at least one adjunctivedistal interventional device, such as an angiographic or guidingcatheter, through a single access site, such as a single femoralarterial puncture.

A need also still exists for improved devices and methods for treating,and in particular preventing, ARF, and in particular relation to RCN orCHF, by locally delivering renal protective or ameliorative drugs intothe renal arteries, such as contemporaneous with radiocontrastinjections such as during angiography procedures.

A need still exists for improved devices to deliver fluid agentsbilaterally to both sides of the renal system from within the aortasystem.

A need still exists for improved devices to deliver fluid agentsbilaterally to both sides of the renal system without requiringcannulation of the renal arteries themselves.

A need also exists for improved devices to deliver fluid agentsbilaterally to both sides of the renal system without substantiallyoccluding, isolating, or diverting blood flow within the abdominalaorta.

In addition to these particular needs for selective fluid delivery intoa patient's renal arteries via their ostia along the aorta, othersimilar needs also exist for fluid delivery into other branch vessels orlumens extending from other main vessels or lumens, respectively, in apatient.

BRIEF SUMMARY OF THE INVENTION

These present embodiments therefore generally relate to intra aorticrenal drug delivery systems generally from a position proximal to therenal arteries themselves; however, it is contemplated that thesesystems and methods may be suitably modified for use in other anatomicalregions and for other medical conditions without departing from thebroad scope of various of the aspects illustrated by the embodiments.For example, intra aortic fluid delivery according to various of theseembodiments benefits from particular dimensions, shapes, andconstructions for the subject devices herein described. However,suitable modifications may be made to deliver fluids to othermulti-lateral branch structures from main body spaces or lumens, such asfor example in other locations within the vasculature (e.g. right andleft coronary artery ostia, fallopian tubes stemming from a uterus, orgastrointestinal tract.

One aspect of the invention is a local renal infusion system fortreating a renal system in a patient from a location within theabdominal aorta associated with first and second flow paths within anouter region of abdominal aortic blood flow generally along theabdominal aorta wall and into first and second renal arteries,respectively, via their corresponding first and second renal ostia alongan abdominal aorta wall in the patient. This system includes a localinjection assembly with first and second injection ports. The localinjection assembly is adapted to be positioned at the location with thefirst and second injection ports at first and second respectivepositions, respectively, corresponding with the first and second flowpaths. The local injection assembly is also adapted to be fluidlycoupled to a source of fluid agent externally of the patient when thelocal injection assembly is positioned at the location. Accordingly, thelocal injection assembly is adapted to inject a volume of fluid agentfrom the source, through the first and second injection ports at thefirst and second positions, respectively, and bi-laterally into thefirst and second renal arteries, also respectively. This assembly is inparticular adapted to accomplish such localized bilateral renal deliveryvia the respective corresponding first and second renal ostia andwithout substantially altering abdominal aorta flow along the location.

According to certain further modes of this aspect, the local injectionassembly is adapted to inject the volume of fluid agent into the firstand second flow paths such that the injected volume flows substantiallyonly into the first and second renal arteries without substantiallydiverting, occluding, or isolating one region of aortic blood flow withrespect to the first or second regions of aortic blood flow.

Another further mode also includes a delivery member with a proximal endportion and a distal end portion with a longitudinal axis. The localinjection assembly comprises first and second injection members withfirst and second injection ports, respectively, and is adapted to extendfrom the distal end portion of the delivery member and is adjustablebetween a first configuration and a second configuration as follows. Thelocal injection assembly in the first configuration is adapted to bedelivered by the delivery member to the location. The local injectionassembly at the location is adjustable from the first configuration tothe second configuration such that the first and second first injectionmembers are radially extended from the longitudinal axis with the firstand second injection ports located at the first and second positions,respectively, at the first and second flow paths.

According to another mode, the local injection assembly includes anelongate body that is adapted to be positioned within the outer region.The first and second injection ports are spaced at different locationsaround the circumference of the elongate body such that the first andsecond injection ports are adapted to inject the volume of fluid agentin first and second different respective directions laterally from theelongate body and generally into the first and second flow paths,respectively.

According to one embodiment of this mode, a positioner cooperates withthe elongate body and is adapted to position the elongate body withinthe outer region at the location. In one variation of this embodiment,the positioner is coupled to the elongate body and is adjustable from afirst configuration to a second configuration. The positioner in thefirst configuration is adapted to be delivered to the location with theelongate body. The positioner at the location is adapted to be adjustedfrom the first configuration to the second configuration that is biasedto radially extend from the elongate body relative to the firstconfiguration and against the abdominal aorta wall with sufficient forceso as to deflect the orientation of the elongate body into the outerregion. Further to this variation the positioner may also beneficiallybe a partial loop-shaped member that extends with first and second legsfrom the elongate body. In the first configuration at the location thepartial loop-shaped member has a first orientation with respect to theelongate body and is adapted to be delivered to the location. In thesecond configuration at the location the partial loop-shaped member hasa second orientation that is radially extended from the elongate bodyrelative to the first orientation. In still further features accordingto this variation, the partial loop-shaped member is adjusted to thefirst configuration when subject to deformation force away from a memoryshape, and is self-adjustable from the first configuration to the secondconfiguration by material recovery of the partial loop-shaped memberfrom the first configuration toward the memory shape. The first andsecond legs may be extendable from the elongate body through first andsecond extension ports, such that in the first configuration the firstand second legs are withdrawn into the elongate body, and in the secondconfiguration the first and second legs are extended from the elongatebody through the first and second extension ports, respectively.

In another embodiment, a control member is coupled to the partialloop-shaped member and also to the elongate body, and is adapted toadjust the looped-shape member between the first and secondconfigurations by manipulating the position of the control member.

In still a further embodiment, the positioner comprises a plurality ofpartial loop-shaped members such as described above.

In another mode of this aspect of the invention, the local injectionassembly further includes an elongate body with a longitudinal axis andthat is adapted to be positioned at the location. The first and secondinjection members in the first configuration have first radial positionsrelative to the longitudinal axis, and in the second configuration havesecond radial positions. The second radial positions are radiallyextended from the longitudinal axis relative to the first radialposition.

In one embodiment of this mode, the first and second injection membersare located on opposite respective sides of the elongate body around acircumference of the elongate body. In one variation of this embodiment,each of the first and second injection members extends between proximaland distal respective locations on each of the opposite respective sidesof the elongate body, and in the second configuration the first andsecond injection members are biased outward from the elongate bodybetween the respective proximal and distal respective locations.

In another embodiment, the local injection assembly is in the form of agenerally loop-shaped member, such that the first and second injectionmembers comprise first and second regions along the loop-shaped member,and whereas the first and second injection ports are located on each ofthe first and second regions. The loop-shaped member in the firstconfiguration has a first diameter between the first and secondinjection ports such that the loop-shaped member is adapted to bedelivered to the location. The loop-shaped member in the secondconfiguration has a second diameter between the first and secondinjection ports that is greater than the first diameter and issufficient such that the first and second positions generally correspondwith first and second flow paths within the outer region, respectively.According to one variation of this embodiment, the local injectionassembly in the second configuration for the loop-shaped member includesa memory shape. The loop-shaped member is adjustable from the secondconfiguration to the first configuration within a radially confiningouter delivery sheath. The loop-shaped member is adjustable from thefirst configuration to the second configuration by removing it fromradial confinement outside of the outer delivery sheath.

In another mode, the local injection assembly comprises a plurality of ninjection members, wherein n is an integer that is greater than two.Further to this mode, n injection ports are located on the n injectionmembers, respectively. Each of the n injection members is adapted to bepositioned at the location such that the n injection ports are locatedat n unique respective positions within the outer region. The localinjection assembly is adapted to be oriented at the location such that nminus two of the plurality of injection members are oriented with thecorresponding n minus two injection ports against the abdominal aortawall, and such that the remaining two injection members of the pluralityare oriented such that the two corresponding injection ports are at thefirst and second positions. Accordingly, the remaining two injectionmembers are the first and second injection members, and the remainingtwo injection ports on the two remaining injection members are the firstand second injection ports.

In one embodiment of this mode, each of the plurality of injection portsat its respectively unique position within the outer region is adaptedto be fluidly coupled simultaneously with the source of fluid agentexternally of the body. The n minus two injection ports are adapted tobe substantially prevented by the abdominal wall from injecting asubstantial volume of fluid agent from the source and into the outerregion. The remaining two injection ports are adapted to inject asubstantial volume of fluid agent from the source and into the first andsecond renal ostia, respectively, such that local injection of fluidagent from the source is substantially isolated to the two injectionports.

In another embodiment, in the first configuration at the location the ninjection members are positioned at n generally unique radiallycollapsed positions around a circumference having a first diameteraround a longitudinal axis of the abdominal aorta at the location. Inthe second configuration at the location the n injection members arepositioned at n generally unique radially expanded positions around acircumference having a second diameter around the longitudinal axis thatis greater than the first outer diameter and that is sufficient toposition the respective n injection ports at the n respective positions,respectively.

According to another mode, each of the first and second injectionmembers includes an infusion passageway with an array of n injectionregions, wherein n is an integer. Each array of n injection regions isadapted to be coupled to the source of fluid agent outside the body. Thefirst and second injection members are adapted to be oriented at thelocation such that x of the n respective injection regions of each arrayare positioned within the outer region and in fluid communication withthe respective renal ostium, and such that y of the respective injectionregions of each array are against the abdominal aorta wall such thatthey are substantially prevented by the abdominal aorta wall frominjecting a volume of fluid agent into the outer region. Accordingly,the first injection port includes at least one of the x injectionregions along the first injection member. The second injection portincludes at least one of the x injection regions along the secondinjection member. Further to this description, in general x is apositive number that is not greater than n, and n is equal to x plus y.

In a further mode of the present aspect, first and second markerslocated along first and second injection members, respectively, atlocations generally corresponding with the first and second injectionports. Each of the first and second markers is adapted to indicate to anoperator externally of the patient the locations of the first and secondinjection ports to assist their delivery to the first and secondpositions, respectively. In particular beneficial embodiments, the firstand second markers are radiopaque and provide guidance underfluoroscopy. In a further embodiment, the first and second injectionmembers extend distally from the delivery member from a bifurcationlocation, and a proximal marker is located at the bifurcation location.

In another mode, a the delivery member is provided that is an introducersheath with a proximal end portion and a distal end portion that isadapted to be positioned at the location with the proximal end portionof the introducer sheath extending externally from the patient. Thedelivery member includes a delivery passageway extending between aproximal port assembly along the proximal end portion of the introducersheath and a distal port assembly along the distal end portion of theintroducer sheath. The injection assembly is adapted to be slideablyengaged within the introducer sheath, and is adjustable between firstand second longitudinal positions. The first and second injectionmembers are located within the delivery passageway in the firstlongitudinal position and are extended distally through the distal portand from the distal end portion in the second longitudinal position. Ina further embodiment of this mode, the distal end portion of theintroducer sheath includes a distal tip and a delivery marker at alocation corresponding with the distal tip such that the delivery markeris adapted to indicate the relative position of the distal tip withinthe abdominal aorta at the location. In one further embodiment, thedistal port assembly has first and second ports through which the firstand second delivery members are extended during adjustment to the secondconfiguration.

In another further embodiment, a catheter body is provided with aproximal end portion and a distal end portion that is adapted to bepositioned at the location when the proximal end portion of the catheterbody extends externally from the patient. The first and second injectionmembers are coupled to and extend distally from the distal end portionof the catheter body. The proximal port assembly of the introducersheath comprises a single proximal port, and the first and secondinjection members and distal end portion of the catheter body areadapted to be inserted into the delivery passageway through the singleproximal port.

According to another mode, the system further includes a proximalcoupler assembly that is adapted to be fluidly coupled to a source offluid agent externally of the patient, and also to the first and secondinjection ports at the first and second positions, respectively.

In one embodiment, the proximal coupler assembly comprises first andsecond proximal couplers. The first proximal coupler is fluidly coupledto the first injection port, and the second proximal coupler is fluidlycoupled to the second injection port. In one variation of thisembodiment, a first elongate body extends between the first proximalcoupler and the first injection member, and with a first fluidpassageway coupled to the first proximal coupler and the first injectionport; a second elongate body extends between the second proximal couplerand the second injection member, and with a second fluid passagewaycoupled to the second coupler and the second injection port. In anothervariation, the proximal coupler assembly includes a single commoncoupler that is fluidly coupled to each of the first and secondinjection ports via a common fluid passageway. According to one featurethat may be employed per this variation, an elongate body extendsbetween the single common coupler and the first and second injectionmembers. The elongate body has at least one delivery passageway fluidlycoupled to the single common coupler and also to the first and secondinjection ports.

According to still a further mode of this aspect of the invention, thesystem further includes a source of fluid agent that is adapted to becoupled to the local injection assembly. The fluid agent may comprisesone, or combinations of, the following: saline; a diuretic, such asFurosemide or Thiazide; a vasopressor, such as Dopamine; a vasodilator;another vasoactive agent; Papaverine; a Calcium-channel blocker;Nifedipine; Verapamil; fenoldapam mesylate; a dopamine DA1 agonist; oranalogs or derivatives, or combinations or blends, thereof.

Another mode includes a vascular access system with an elongate tubularbody with at least one lumen extending between a proximal port assemblyand a distal port that is adapted to be positioned within a vesselhaving translumenal access to the location. The system per this modealso includes a percutaneous translumenal interventional device that isadapted to be delivered to an intervention location across the locationwhile the local injection assembly is at the location. The localinjection assembly and percutaneous translumenal interventional deviceare adapted to be delivered percutaneously to the location andintervention location, respectively, through the vascular access device,and are also adapted to be simultaneously engaged within the vascularaccess device.

In one embodiment, the percutaneous translumenal interventional devicecomprises an angiographic catheter. In another, the percutaneoustranslumenal interventional device is a guiding catheter. In anotherregard, the interventional device may be between about 4 French andabout 8 French.

In another embodiment, the proximal port assembly includes first andsecond proximal ports. The percutaneous translumenal interventionaldevice is adapted to be inserted into the elongate body through thefirst proximal port. The first and second ports of the injectionassembly are adapted to be inserted into the elongate body through thesecond proximal port.

According to another mode, the local injection assembly includes a fluidreservoir and the first injection port is fluidly coupled to the fluidreservoir. The fluid reservoir is adjustable between a first condition,a second condition, and a third condition. In the first condition thefluid reservoir is adapted to be delivered to the location with thefirst injection port at the first position at the location. The fluidreservoir at the location is adapted to be fluidly coupled to a sourceof fluid agent located externally of the patient. The fluid reservoir atthe location is adjustable from the first condition to the secondcondition such that the first volume from the source is delivered intothe fluid reservoir. The local injection assembly at the location isfurther adjustable from the second condition to the third conditionwherein the fluid reservoir discharges the first volume of fluid agentthrough the injection port at the position. The injected first volume offluid agent is adapted to flow principally into the first flow path.

Another aspect is a local infusion system for locally delivering avolume of fluid agent from a source located externally of a patient andinto a location within a body space of a patient. This system includes adelivery member with a proximal end portion and a distal end portionwith a longitudinal axis, and a local injection assembly comprisingfirst and second injection members with first and second injectionports, respectively. The local injection assembly extends from thedistal end portion of the delivery member and is adjustable between afirst configuration and a second configuration as follows. The localinjection assembly in the first configuration is adapted to be deliveredby the delivery member to the location. The local injection assembly atthe location is adjustable from the first configuration to the secondconfiguration such that the first and second first injection members areradially extended from the longitudinal axis with the first and secondinjection ports located at first and second relatively unique positions,respectively, at the location. The first and second injection ports atthe first and second respective positions are adapted to be fluidlycoupled to a source of fluid agent externally of the patient and toinject a volume of fluid agent into the patient at the first and secondpositions, also respectively, at the location.

Another aspect of the invention is a local infusion system with a localinjection assembly comprising an injection member with an injection portand a fluid reservoir fluidly coupled to the injection port. The localinjection assembly is adjustable between a first condition, a secondcondition, and a third condition as follows. In the first condition thelocal injection assembly is adapted to be delivered to a location withina body space of a patient with the injection port and fluid reservoir ata position within the location. The injection port at the position isadapted to be fluidly coupled to a source of fluid agent locatedexternally of the patient. The local injection assembly at the locationis adjustable from the first condition to the second condition such thata volume of fluid agent from the source is delivered via the injectionport into the fluid reservoir. The local injection assembly at thelocation is further adjustable from the second condition to the thirdcondition wherein the fluid reservoir discharges the volume of fluidagent into the location at the position.

Another aspect of the invention is a local infusion system fordelivering a volume of fluid agent from a source located externally of apatient and into a portion of an outer region within and generally alonga wall of a body space at a location along the body space in thepatient. The system includes a local injection assembly with aninjection port, and a flow isolation assembly that cooperates with thelocal injection assembly as follows. The local injection assembly isadapted to be delivered to the location with the injection port at aposition within the portion of the outer region. The injection port atthe position is adapted to be fluidly coupled to a source of fluid agentlocated externally of the patient and to inject a volume of fluid agentfrom the source into the portion of the outer region of the body space.The flow isolation assembly is adjustable between a first condition anda second condition as follows. The flow isolation assembly in the firstcondition is adapted to be delivered to the location. The flow isolationassembly at the location is adjustable from the first condition to asecond condition that is adapted to isolate the injected volume of fluidagent to flow substantially within the portion of the outer region alongthe location. The portion is located along only a part of thecircumference of the outer region that is less than all of thecircumference.

Another aspect of the invention is a local renal infusion system fortreating a renal system in a patient from a location within theabdominal aorta associated with abdominal aortic blood flow into firstand second renal arteries via respective first and second renal ostiahaving unique relative locations along the abdominal aorta wall. Thissystem includes in one regard a delivery catheter with an elongate bodyhaving a proximal end portion, a distal end portion with a distal tipthat is adapted to be delivered across the location and to a deliverylocation that is upstream of the location while the proximal end portionis located externally of the patient, and a delivery lumen extendingbetween a proximal port along the proximal end portion and a distal portalong the distal end portion. A local injection assembly is alsoprovided with an injection port. The local injection assembly is adaptedto be delivered at least in part by the elongate body to the locationsuch that the injection port is at a position within the location whilethe distal tip of the delivery catheter is at the delivery position. Theinjection port at the location is adapted to be fluidly coupled to asource of fluid agent located externally of the patient and to inject avolume of fluid agent from the source into abdominal aorta at thelocation such that the injected volume flows substantially into thefirst and second arteries via the first and second renal ostia,respectively.

Another aspect of the invention is a method for treating a renal systemin a patient from a location within the abdominal aorta associated withabdominal aortic blood flow into first and second renal arteries viarespective first and second renal ostia having unique relative locationsalong the abdominal aorta wall. This method includes in one regarddelivering a delivery catheter with an elongate body having a proximalend portion and a distal end portion with a distal tip across thelocation and to a delivery location that is upstream of the locationwhile the proximal end portion is located externally of the patient. Themethod further includes delivering a local injection assembly thatincludes an injection port at least in part by the elongate body to thelocation such that the injection port is at a position within thelocation while the distal tip of the delivery catheter is at thedelivery position. The injection port at the location is fluidly coupledto a source of fluid agent located externally of the patient. A volumeof fluid agent from the source is injected through the injection portand into abdominal aorta at the location such that the injected volumeflows substantially into the first and second arteries via the first andsecond renal ostia, respectively.

Another aspect of the invention is a method for treating a renal systemin a patient from a location within the abdominal aorta associated withabdominal aortic blood flow into first and second renal arteries viatheir respective first and second renal ostia, respectively, at uniquerespective locations along the abdominal aorta wall. This methodincludes: positioning a local injection assembly at the location withfirst and second injection ports at first and second unique respectivepositions at the location. Also includes is fluidly coupling the localinjection assembly at the location to a source of fluid agent externallyof the patient. A further step includes simultaneously injecting avolume of fluid agent from the source through the first and secondinjection ports at the first and second positions and principally intothe first and second renal arteries, respectively.

Another aspect of the invention is a method for treating a renal systemin a patient from a location within the abdominal aorta associated withabdominal aortic blood flow into each of first and second renal arteriesvia first and second renal ostia, respectively, at unique respectivelocations along the abdominal aorta wall. This method includespositioning a local injection assembly at the location, and fluidlycoupling to the local injection assembly at the location to a source offluid agent externally of the patient. Also included is injecting avolume of fluid agent from the source and into the abdominal aorta atthe location in a manner such that the injected fluid flows principallyinto the first and second renal arteries via the first and second renalostia, respectively, and without substantially occluding or isolating asubstantial portion of an outer region of aortic blood flow along acircumference of the abdominal aorta wall and across the location.

Another aspect of the invention is a method for treating a renal systemin a patient from a location within the abdominal aorta associated withabdominal aortic blood flow into each of first and second renal arteriesvia first and second renal ostia, respectively, at unique respectivelocations along the abdominal aorta wall. This method aspect includespositioning a delivery member within an abdominal aorta of a patient,and delivering with the delivery member a local injection assemblyhaving first and second injection members with first and secondinjection ports, respectively, in a first configuration to the location.Also included is adjusting the local injection assembly between thefirst configuration and a second configuration at the location. Furtherto this method, in the second configuration the local injection assemblyextends from the distal end portion of the delivery member with thefirst and second first injection members radially extended relative toeach other across a portion of the abdominal aorta at the location andwith the first and second injection ports located at first and secondrelatively unique positions, respectively, at the location. A furthermode of this aspect is fluidly coupling the first and second injectionports at the first and second respective positions to a source of fluidagent externally of the patient, and injecting a volume of fluid agentinto the first and second renal arteries via their respective first andsecond renal ostia from the first and second positions, respectively.

Another aspect of the invention is a method for treating a renal systemin a patient from a location within the abdominal aorta associated withabdominal aortic blood flow into a renal artery via a renal ostiumlocated along the abdominal aorta wall. This method includes deliveringa local injection assembly comprising an injection member with a fluidreservoir and an injection port in a first condition to the locationwith the injection port at a position at the location. Also included isfluidly coupling the fluid reservoir at the location to a source offluid agent located externally of the patient. Further steps includeadjusting the local injection assembly at the location from the firstcondition to a second condition such that a volume of fluid agent fromthe source is delivered into the fluid reservoir, and adjusting thelocal injection assembly at the location from the second condition to athird condition wherein the fluid reservoir discharges the volume offluid agent through the injection port at the position. Accordingly, theinjected volume of fluid agent is adapted to flow principally into therenal artery via the renal ostium.

Another method aspect of the invention is a method for treating a renalsystem in a patient from a location within the abdominal aortaassociated with abdominal aortic blood flow into a renal artery via arenal ostium located along the abdominal aorta wall. This methodincludes delivering a local injection assembly with an injection port tothe location with the injection port at a position within a portion ofan outer region of the abdominal aortic blood flow generally along theabdominal aorta wall at the location. Further included is fluidlycoupling the injection port at the position to a source of fluid agentlocated externally of the patient and to inject a volume of fluid agentfrom the source into the portion of the outer region. Further steps aredelivering a flow isolation assembly in a first condition to thelocation, adjusting the flow isolation assembly at the location from thefirst condition to a second condition, and isolating the injected volumeof fluid agent to flow substantially within the portion of the outerregion along the location with the flow isolation assembly in the secondcondition. According to this method, the portion is located along only apart of the circumference of the outer region that is less than all ofthe circumference.

Another aspect of the invention is a method for providing local therapyto a renal system in a patient from a location within the abdominalaorta associated with first and second flow paths within an outer regionof abdominal aortic blood flow generally along the abdominal aorta walland into first and second renal arteries, respectively, via theircorresponding first and second renal ostia along an abdominal aorta wallin the patient. This method includes positioning a local injectionassembly at the location with first and second injection ports at firstand second respective positions, respectively, corresponding with thefirst and second flow paths. Also included is fluidly coupling the localinjection assembly to a source of fluid agent externally of the patientwhen the local injection assembly is positioned at the location, andinjecting a volume of fluid agent from the source, through the first andsecond injection ports at the first and second positions, respectively,and bi-laterally into the first and second renal arteries, alsorespectively, via the respective corresponding first and second renalostia without substantially altering abdominal aorta flow along thelocation.

Further modes of these various method aspects include beneficiallyenhancing renal function with the injected volume of fluid agent. Thismay include in particular injecting the volume of fluid agent into thelocation while performing an interventional procedure at an interventionlocation within a vasculature of the patient. In one embodiment, thisfurther includes injecting the volume of fluid agent during a periodwhen a volume of radiocontrast dye injection is within the patient'svasculature, and such that the fluid agent is adapted to substantiallyprevent RCN in response to the radiocontrast dye injection. According toa further beneficial variation, the method includes treating acute renalfailure with the injected volume of fluid agent.

Whereas each of these aspects, modes, embodiments, variations, andfeatures is considered independently beneficial and are not to berequired in combination with the others, nevertheless the variouscombinations and sub-combinations thereof as would be apparent to one ofordinary skill are further considered within the intended scope asfurther independently beneficial aspects of the invention.

Further aspects of the invention will be brought out in the followingportions of the specification, wherein the detailed description is forthe purpose of fully disclosing preferred embodiments of the inventionwithout placing limitations thereon.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood by reference to thefollowing drawings which are for illustrative purposes only:

FIG. 1 is an anterior perspective view of an abdominal aorta in thegenerally vicinity of the renal arteries.

FIG. 2 is a cross-section view of an abdominal aorta taken in thevicinity of the renal arteries showing the general blood flow patternsthrough the abdominal aorta and the renal arteries.

FIG. 3 is an anterior view of an embodiment of a bifurcated fluidinfusion catheter disposed within an abdominal aorta in the vicinity ofthe renal arteries.

FIG. 4 is a detailed view of one portion of the fluid infusion assemblyshown in FIG. 3 in a diastole configuration.

FIG. 5 is a detailed view of the portion of the fluid infusion assemblyshown in FIG. 4, except shows it in a systole configuration.

FIG. 6 is a detailed view of another fluid infusion assembly in adiastole configuration.

FIG. 7 is a detailed view of the fluid infusion assembly shown in FIG.6, except shows it in a systole configuration.

FIG. 8 is a perspective view of another form of bifurcated drug infusioncatheter in an expanded configuration.

FIG. 9 is a side plan view of the bifurcated drug infusion cathetershown in FIG. 8, except shows the catheter in a collapsed configuration.

FIG. 10 is an anterior view of another bifurcated drug infusion catheterembodiment with an infusion ring shown in an expanded configuration.

FIG. 11 is an anterior view of the bifurcated fluid infusion catheterembodiment shown in FIG. 10, shown in one mode of operation dischargingmedication.

FIG. 12 is an anterior view of the bifurcated drug infusion catheter ofFIGS. 10 and 11, and shows it disposed within an abdominal aortaadjacent to the renal arteries.

FIG. 13 is a left side plan view of the bifurcated drug infusioncatheter shown in FIGS. 10-12, and shows one mode of use disposed withinan abdominal aorta adjacent to the renal arteries.

FIG. 14 is an anterior view of the bifurcated drug infusion cathetershown in FIGS. 10-12, and shows another mode of use disposed within anabdominal aorta immediately above the renal arteries.

FIG. 15 is a plan view of a fluid infusion catheter with positioningstruts according to a further embodiment, and shows the struts in acollapsed configuration.

FIG. 16 is an anterior view of the fluid infusion catheter shown in FIG.15, shown with the struts disposed within an abdominal aorta adjacent tothe renal arteries in an expanded configuration.

FIG. 17 is a plan view of another fluid infusion catheter with strutsshown in a collapsed configuration.

FIG. 18 is an anterior view of the fluid infusion catheter shown in FIG.17, and shows the positioning struts disposed within an abdominal aortaadjacent to the renal arteries in an expanded configuration.

FIG. 19 is a plan view of another fluid infusion catheter withpositioning struts shown in a collapsed configuration.

FIG. 20 is an anterior view of the fluid infusion catheter of FIG. 19,and shows the struts disposed within an abdominal aorta adjacent to therenal arteries in an expanded configuration.

FIG. 21 is an anterior view of another fluid infusion catheter with ananchor disposed within an abdominal aorta adjacent to the renal arteriesin an expanded configuration.

FIG. 22 is a detailed view of certain aspects of the fluid infusioncatheter shown in FIG. 21.

FIG. 23 is a detailed view of the fluid infusion catheter taken atcircle 23 in FIG. 21.

FIG. 24 is an anterior view of another fluid infusion catheter with apositioning loop disposed within an abdominal aorta immediately abovethe renal arteries in an extended configuration.

FIG. 25 is a top plan view of the fluid infusion catheter shown in FIG.24, and shows the positioning loop is disposed within an abdominal aortaimmediately above the renal arteries in an extended configuration.

FIG. 26 is a side plan view of the fluid infusion catheter shown inFIGS. 24-25, and shows the positioning loop disposed within an abdominalaorta immediately above the renal arteries in an extended configuration.

FIG. 27 is a second side plan view of the fluid infusion catheter shownin FIGS. 24-25, and shows the positioning loop disposed within anabdominal aorta immediately above the renal arteries in an extendedconfiguration.

FIG. 28 is an anterior view of another fluid infusion catheter with anadjustable positioning loop in a retracted configuration.

FIG. 29 is an anterior view of another fluid infusion catheter with apositioning loop in a partially extended configuration.

FIG. 30 is a anterior view of another fluid infusion catheter withpositioning loops in an extended configuration.

FIG. 31 is a top plan view of the fluid infusion catheter shown in FIG.30, and shows the positioning loops in an extended configuration.

FIG. 32 is a perspective view of another embodiment according to theinvention with a fluid infusion catheter cooperating with a flowdiverter.

FIG. 33 is an anterior view of the fluid infusion catheter shown in FIG.32, and shows the flow diverter disposed within an abdominal aortaadjacent to the renal arteries.

FIG. 34 is a perspective view of another drug infusion catheter with aflow diverter according to a further embodiment.

FIG. 35 is an anterior view of the fluid infusion catheter shown in FIG.34, and shows the flow diverter disposed within an abdominal aortaadjacent to the renal arteries.

FIG. 36 is a perspective view of another fluid infusion catheter with aflow diverter according to still a further embodiment.

FIG. 37 is a side plan view of another embodiment of the fluid infusioncatheter with flow diverter shown in FIG. 36.

FIG. 38 is an anterior view of the fluid infusion catheter shown inFIGS. 36-37, and shows the flow diverter disposed within an abdominalaorta adjacent to the renal arteries.

FIG. 39 is an anterior view of a fluid infusion guide catheter disposedwithin an abdominal aorta adjacent to the renal arteries.

FIG. 40 is an anterior view of another fluid infusion guide catheterdisposed within an abdominal aorta adjacent to the renal arteries.

FIG. 41 is an anterior view of another fluid infusion guide catheterdisposed within an abdominal aorta adjacent to the renal arteries.

FIG. 42 is a plan view of the fluid infusion guide catheter shown inFIG. 41, except showing in another collapsed mode of use.

FIG. 43 is an anterior view of a guide catheter with a coaxial druginfuser disposed within an abdominal aorta adjacent to the renalarteries according to another embodiment.

FIG. 44 is a top plan view of the system shown in FIG. 43.

FIG. 45 is an anterior view of another guide catheter with a coaxialdrug infuser disposed within an abdominal aorta adjacent to the renalarteries.

FIG. 46 is a perspective view of another catheter assembly with a druginfusion introducer sheath disposed within an abdominal aorta adjacentto the renal arteries.

FIG. 47 is a perspective view of another catheter assembly with aninfusion balloon disposed within an abdominal aorta adjacent to therenal arteries.

FIG. 48 is a rear perspective view of a self-shaping drug infusioncatheter in a first configuration.

FIG. 49 is an anterior view of a self-shaping drug infusion catheter ina second shaped configuration and disposed within an abdominal aortaadjacent to the renal arteries.

FIG. 50 is a top plan view of a self-shaping drug infusion catheter in ashaped configuration and disposed within an abdominal aorta adjacent tothe renal arteries.

FIG. 51 is a side plan view of a self-shaping drug infusion catheterassembly.

FIG. 52 is a side view of another embodiment of a catheter fluiddelivery system with a multilumen sheath.

FIG. 53 is a top section view of the catheter fluid delivery system inFIG. 52.

FIG. 54 illustrates a proximal coupler system for positioning aorticfluid delivery systems adjunctively with other medical devices.

FIG. 55 illustrates a section view of the proximal coupler system asshown in FIG. 54.

FIG. 56A illustrates a proximal coupler system as shown in FIG. 54coupled to a local fluid delivery system.

FIG. 56B illustrates a proximal coupler system as shown in FIG. 56A witha fluid delivery system advanced into an introducer sheath.

FIG. 57 illustrates a proximal coupler system as shown in FIG. 54through 56B with a fluid infusion device positioned near the renalarteries and a catheter deployed adjunctively in the aorta.

FIG. 58 illustrates a renal therapy system with an introducer sheathsystem, a vessel dilator, a fluid delivery system and an aortic infusionassembly.

FIG. 59 is a stylized illustration of a double Y assembly with two localfluid delivery systems and an intervention catheter in an aorta system.

DETAILED DESCRIPTION OF THE INVENTION

Referring more specifically to the drawings, for illustrative purposesthe present invention is embodied in the apparatus generally shown inFIG. 3 through FIG. 59. It will be appreciated that the apparatus mayvary as to configuration and as to details of the parts, and that themethod may vary as to the specific steps and sequence, without departingfrom the basic concepts as disclosed herein.

The description herein provided relates to medical material deliverysystems and methods in the context of their relationship in use within apatient's anatomy. Accordingly, for the purpose of providing a clearunderstanding, the term proximal should be understood to mean locationson a system or device relatively closer to the operator during use, andthe term distal should be understood to mean locations relativelyfurther away from the operator during use of a system or device. Thesepresent embodiments below therefore generally relate to local renal drugdelivery generally from the aorta; however, it is contemplated thatthese systems and methods may be suitably modified for use in otheranatomical regions and for other medical conditions without departingfrom the broad scope of various of the aspects illustrated by theembodiments.

In general, the disclosed material delivery systems will include a fluiddelivery assembly, a proximal coupler assembly and one or more elongatedbodies, such as tubes or catheters. These elongated bodies may containone or more lumens and generally consist of a proximal region, amid-distal region, and a distal tip region. The distal tip region willtypically have means for delivering a material such as a fluid agent.Radiopaque markers or other devices may be coupled to the specificregions of the elongated body to assist introduction and positioning.

The material delivery system is intended to be placed into position by aphysician, typically either an interventionalist (cardiologist orradiologist) or an intensivist, a physician who specializes in thetreatment of intensive-care patients. The physician will gain access toa femoral artery in the patient's groin, typically using a Seldingertechnique of percutaneous vessel access or other conventional method.

For additional understanding, further more detailed examples of othersystems and methods for providing local renal drug delivery arevariously disclosed in the following published references: WO 00/41612to Keren et al.; and WO 01/083016 to Keren et al. The disclosures ofthese references are herein incorporated in their entirety by referencethereto. Moreover, various combinations with, or modifications accordingto, various aspects of the present embodiments as would be apparent toone of ordinary skill upon review of this disclosure together with thesereferences are also considered within the scope of invention asdescribed by the various independently beneficial embodiments describedbelow.

The invention is also related to subject matter disclosed in otherPublished International Patent Applications as follows: WO 00/41612 toLibra Medical Systems, published Jul. 20, 2000; and WO 01/83016 to LibraMedical Systems, published Nov. 8, 2001. The disclosures of thesePublished International Patent Applications are also herein incorporatedin their entirety by reference thereto.

Referring initially to FIG. 1, an abdominal aorta is shown and isgenerally designated 10. As shown, a right renal artery 12 and a leftrenal artery 14 extend from the abdominal aorta 10. A superiormesenteric artery 16 extends from the abdominal aorta 10 above the renalarteries 12, 14. Moreover, a celiac artery 18 extends from the abdominalaorta 10 above the superior mesenteric artery 16. FIG. 1 also shows thatan inferior mesenteric artery 20 extends from the abdominal aorta 10below the renal arteries 12, 14. Further, as shown in FIG. 1, theabdominal aorta 10 branches into a right iliac artery 22 and a leftiliac artery 24. It is to be understood that each embodiments of thepresent invention described in detail below can be used to deliver adrug or other fluid solution locally into the renal arteries 12, 14.Each of the below-described embodiments can be advanced through one ofthe iliac arteries 22, 24 and into the abdominal aorta 10 until thegeneral vicinity of the renal arteries 12, 14 is reached.

FIG. 2 shows a schematic cross-section of the abdominal aorta 10 takenin the immediate vicinity of the renal arteries 12, 14. FIG. 2 shows thenatural flow patterns through the abdominal aorta 10 and the naturalflow patterns from the abdominal aorta 10 into the renal arteries 12,14. As shown, the flow down the abdominal aorta 10 maintains a laminarflow pattern. Moreover, the flow stream near the middle of the abdominalaorta 10, as indicated by dashed box 30, continues down the abdominalaorta 10, as indicated by arrows 32, and does not feed into any of theside branches, e.g., the renal arteries 12, 14. As such, a drug solutioninfusion down the middle of the abdominal aorta flow stream can beineffective in obtaining isolated drug flow into the renal arteries 12,14.

Conversely, the flow stream along an inner wall 34 of the abdominalaorta 10, as indicated by dashed box 36 and dashed box 38, contains anatural laminar flow stream into the branching arteries, e.g., the renalarteries 12, 14, as indicated by arrows 40, 42. In general, the flowstream 32 is of a higher velocity than flow stream 40 along wall 34 ofaorta 10. It is to be understood that near the boundaries of dashed box36,38 with dashed box 30 the flow stream can contain flow streams intothe branching arteries 12, 14—as well as down the abdominal aorta 10.

Further, the ostia of renal arteries 12, 14 are positioned to receivesubstantial blood flow from the blood flow near the posterior wall 34 ofaorta 10 as well as the side walls. In other words, blood flow 40 indashed boxes 36, 38 together is greater than blood flow 32 in dashed box30 when along the posterior wall of aorta 10 relative to blood flow inthe center of aorta 10 as shown in FIG. 2. Thus, drug infusion aboverenal arteries 12,14 and along the posterior wall of aorta 10 will beeffective in reaching renal arteries 12,14.

Accordingly, in order to maximize the flow of a drug solution into therenal arteries using the natural flow patterns shown in FIG. 2, it isbeneficial to provide a device, as described in detail below, that isadapted to selectively infuse a drug solution along the side wall orposterior wall of the abdominal aorta 10 instead of within the middle ofthe abdominal aorta 10 or along the anterior wall.

As described in much greater detail below, it is beneficial to infuse adrug solution above the renal arteries 12, 14 at two locations along thewall 34 of the abdominal aorta 10 spaced approximately one-hundred andeighty degrees (180) apart from each other.

Referring now to FIG. 3, a first embodiment of a bifurcated druginfusion catheter is shown and is generally designated 50. As shown, thebifurcated drug infusion catheter 50 includes a central catheter body 51that splits into a first bifurcated portion 52 and a second bifurcatedportion 54. Each bifurcated portion 52, 54 includes a free end 56 inwhich an infusion port 58 is formed. Each free end 56 further includes aradio-opaque marker band 59. Also, an infusion assembly 60 is attachedto the free end 56 of each bifurcated portion 52, 54 around the infusionport 58. Details concerning the construction of each infusion assembly60 are described below.

It can be appreciated that the bifurcated drug infusion catheter 50shown in FIG. 3, places a bifurcated portion 52, 54 on the inner wall 34of the abdominal aorta 10 generally immediately upstream from the levelof the renal arteries 12, 14. The infusion ports 58 are positionedinside an infusion assembly 60, described below, that releases a drugsolution during the systolic phase of blood flow in which the blood flowwithin the abdominal aorta 10 is more predictable and more closelytracks the wall 34 of the abdominal aorta 10 into the renal arteries 12,14, as indicated by arrows 62.

It can be further appreciated that the infusion of a drug solution fromthe bifurcated portions 52, 54 of the bifurcated drug infusion catheter50, when positioned adjacent to the inner wall 34 of the abdominal aorta10, results in a greater percentage of the drug solution entering therenal arteries 12, 14 than systemic injection. However, “mixing” intothe center of the abdominal aorta 10 can still take place, e.g., duringthe diastolic phase of blood flow through the abdominal aorta 10. Thus,releasing a drug solution from a properly positioned bifurcated druginfusion catheter 50 during the systolic phase, when a more uniform flowpattern is present, can result in a majority of the drug solutionflowing into the renal arteries 12, 14. Further, a “passive” infusionassembly, as described below, allows the bifurcated drug infusioncatheter 50 to work in a beneficial manner with improved efficiency andreduced complexity. While it is technically feasible to pulse theinjection of a drug with an electro mechanical device driven by an ECGsignal it is beyond the scope of the desired level of complexitydesired.

Referring now to FIG. 4 and FIG. 5, details concerning the constructionof one embodiment of the infusion assembly 60 attached to eachbifurcated portion 52, 54 of the bifurcated drug infusion catheter 50are shown. As shown, the infusion assembly 60 includes a collapsibletube 64 having a proximal end 66 and a distal end 68. Further, a one waycheck valve 70 is installed in the distal end 68 of the collapsible tube64.

FIG. 4 shows the infusion assembly 60 in the diastole configuration inwhich the one way check valve 70 is closed. It can be appreciated thatduring diastole, as indicated by arrow 72, a drug solution 74 tricklingfrom the infusion port 58 can collect in the tube 64 where it isprevented from mixing into the middle of the abdominal aorta 10.However, during systole, as indicated by arrow 76 in FIG. 5, theinfusion assembly 60 moves to the systole configuration, wherein bloodflow opens the one way check valve 70 and the drug solution 74 flows outof the infusion assembly 60, along the wall 34 of the abdominal aorta10, and into the renal artery 14.

FIG. 6 and FIG. 7 show another embodiment of an infusion assembly,designated 80, that can be used in conjunction with the bifurcated druginfusion catheter 50 shown in FIG. 3. As shown in FIG. 6 and FIG. 7, theinfusion assembly 80 includes a collapsible sock 82 having a distal end84 and a proximal end 86.

During diastole, as indicated by arrow 88 in FIG. 6, the infusionassembly 80 is the diastole configuration wherein the drug solution 74from the infusion port 58 can collect in the collapsible sock 82. Withinthe collapsible sock 82, during diastole, the drug solution 74 isprevented from mixing into the middle of the abdominal aorta 10.However, during systole, as indicated by arrow 90 in FIG. 7, theinfusion assembly 80 moves to the systole configuration, wherein theblood flow causes the collapsible sock 82 to collapse and the drugsolution 74 flows out of the infusion assembly 80, along the wall 34 ofthe abdominal aorta 10, and into the renal artery 14.

It can be appreciated that the bifurcated drug infusion catheter 50,shown in FIG. 3, can be used with either of the above-described infusionassemblies 60, 80. Further, during use, the bifurcated drug infusioncatheter 50 can be introduced through a long 8 or 9 French (Fr) diameterintroducer sheath positioned near the renal arteries 12, 14. Thereafter,partially withdrawing the introducer sheath can expose the free ends 56of the bifurcated portions 52, 54 of the bifurcated drug infusioncatheter 50 until separation can be detected, e.g., at approximatelyone-half (½) of the diameter of the abdominal aorta 10. Viewing in anA-P plane the bifurcated drug infusion catheter 50 can be rotated backand forth until the marker bands 59 are in the most lateral position,i.e., when the distance between the marker bands 59 appears to be thegreatest. Then, the longitudinal position of the bifurcated druginfusion catheter 50 can be fine tuned. A user, e.g., a physician, cancontinue to withdraw the introducer sheath until the free ends 56 of thebifurcated drug infusion catheter 50 are in contact with the inner wall34 of the aorta 10. It can be appreciated that the bifurcated druginfusion catheter 50 can be held in place within the abdominal aorta 10by a spring force separating the bifurcated portions 52, 54 of thebifurcated drug infusion catheter 50. It can be further appreciated thateach of the embodiments shown in FIGS. 3-7 are relatively easy toposition, present limited surface area, and minimize flow stagnation.Moreover, upstream interventions may be performed, e.g. PCA.

Referring now to FIG. 8 and FIG. 9, another embodiment of a bifurcateddrug infusion catheter is shown and is designated 100. As shown, thebifurcated drug infusion catheter 100 includes a central catheter tube102. In one beneficial embodiment, catheter tube 102 is multilumen. Afirst infusion tube 104 and a second infusion tube 106, made of aflexible material such as nickel-titanium tubing, are coupled to andextend from the central catheter tube 102 at approximately one-hundredand eighty degrees (180°) from each other. Each infusion tube 104, 106includes a proximal end 108 and a distal end 110. In one beneficialembodiment, the distal ends 110 of each infusion tube 104, 106 arecoupled to the central catheter tube 102 and the proximal ends 108 entercatheter tube 102 and continue proximally to a proximal coupler assembly(not shown). It is to be understood that during drug infusion, a drugsolution can flow from the central catheter tube 102 and through eachinfusion tube 104, 106, e.g., from the proximal end 108 to the distalend 110, or from the distal end 110 to the proximal end 108, but drugsolution principally exits through ports 112.

FIG. 8 and FIG. 9 show the infusion tubes 104, 106 in an expandedconfiguration and a retracted configuration respectively. In oneembodiment, the infusion tubes 104, 106 are advanced distally from aproximal coupler assembly (not shown) causing each infusion tube 104,106 to bow outward in the expanded configuration shown in FIG. 8. Wheninfusion tubes 104, 106 are retracted proximally from a proximal couplerassembly (not shown), they straighten in the retracted configurationshown in FIG. 9.

FIG. 8 and FIG. 9 further show that each infusion tube 104, 106 isformed with an infusion port 112 from which a drug solution can flowduring drug infusion. Moreover, each infusion tube 104, 106 includes amarker band 114 to assist in properly positioning the bifurcatedcatheter tube 100 within the abdominal aorta 10 (FIG. 1).

FIG. 8 shows the bifurcated drug infusion catheter 100 in the expandedconfiguration. When expanded, the infusion tubes 104, 106 can bow awayfrom the central catheter tube 102 in order to provide drug infusionnearer to the inner wall 34 (FIG. 1) of the abdominal aorta 10 (FIG. 1)and maintain positioning within aorta 10. When there is no longer a needfor drug infusion, the infusion tubes 104, 106, are retracted againstthe central catheter tube 102. In the retracted configuration, shown inFIG. 9, the bifurcated drug infusion catheter 100 can be inserted intothe abdominal aorta 10, e.g., from the right iliac artery 22 or the leftiliac artery 24. Additionally, following drug infusion, the infusiontubes 104, 106 can retract and aid in removal of the bifurcated druginfusion catheter 100 from the abdominal aorta 10 (FIG. 1).

It is to be understood that one or more additional struts or tubes (notshown) may be added to catheter 100 to position or stabilize theinfusion tubes 104, 106 near the renal arteries. It is furtherunderstood that the additional struts may be made of different materialsthan the infusion tubes 104, 106.

FIG. 10 through FIG. 14 show various modes according to a furtherembodiment of a bifurcated fluid infusion catheter, generally configuredas an infusion ring, and designated 120. FIGS. 10 through 14 show thatthe bifurcated drug infusion catheter 120 includes a central cathetertube 122 that defines a proximal end (not shown) and a distal end 124.An infusion ring 126 is attached to the distal end 124 of the centralcatheter tube 122. More specifically, the infusion ring 126 includes afirst end 128 and a second end 130 that are attached to the distal end124 of the central catheter tube 122. During infusion, a drug solutioncan flow from the central catheter tube 122 into the infusion ring 126via the first end 128 and second end 130 thereof.

Still referring to FIG. 10 through FIG. 14, the infusion ring 126 ispreferably formed with a first infusion port 132 and a second infusionport 134. In a beneficial embodiment, the infusion ports 132, 134 arelocated along the infusion ring 126 at approximately one-hundred andeighty degrees (180°) from each other. FIG. 10 through FIG. 14 furthershow that the infusion ring 126 includes plural radio-opaque markerbands 136. As shown in FIG. 11, during infusion, a drug solution 138 canflow from the infusion ports 132, 134, e.g., at or above the renalarteries 12, 14.

It can be appreciated that the infusion ring 126 can be made of amaterial having a radial strength sufficient enough to maintain theinfusion ring 126 against the inner wall 34 of the abdominal aorta 10,as shown in FIG. 12. However, the infusion ring 126 is sufficientlyflexible to allow it to become slightly squashed, i.e., elliptical,during insertion. Further, it can be appreciated that the infusion ring126 can be radio-opaque in order to aid in locating and positioning theinfusion ring 126 within the abdominal aorta 10. The marker bands 138can aid in positioning the infusion ports 132, 134.

As shown in FIG. 12 and FIG. 13, the location of the infusion ring 126can be exactly at the renal arteries 12, 14, i.e., with the infusionports 132, 134 aligned with the renal arteries 12, 14, in order tomaximize drug infusion into the renal arteries 12, 14.

One benefit of the infuser ring configuration is it is easy to position,visualize, advance and retract in the aorta. Another benefit is it islow profile. This allows guide catheters and guide wires to pass andreduces thrombus formation due to flow disruption. The low profile lowbulk of the infusion ring allows insertion using smaller diametersheaths. In one beneficial embodiment, the infusion ring is made of amemory shape material such as Nitinol tubing, vertically oriented, andfed through an introducer sheath in a collapsed state to its positionnear the renal arteries. In another embodiment, the infusion ring is aflexible free form material and a pull wire is extended through theinfusion ring to control expansion of the ring and does not requireplacement by an introducer sheath. This configuration also allowsrotational positioning in a contracted state without the risk of vesseltrauma. In a further embodiment, additional homodynamic aids (wings,spoilers, flow directors, etc.) can be coupled on the Nitinol loop inareas which cause limited flow disruption (i.e. simply against theaortas' posterior wall).

FIG. 13 shows a configuration where the bifurcated drug infusioncatheter 120 is installed within the abdominal aorta 10 and the centralcatheter tube 122 rests against the back of the abdominal aorta 10 whilethe infusion ring 126 is at an angle with respect to the abdominal aorta10. This configuration is beneficial to allow guide catheters and guidewires to pass through the infusion ring 126.

On the other hand, as shown in FIG. 14, the infusion ring 126 can beplaced above the renal arteries 12, 14 with the infusion ports 132, 134slightly distanced from the renal arteries 12, 14. Due to the flowpattern discussed above in conjunction with FIG. 2, no vessel or sidebranch can disturb the flow stream above the renal arteries 12, 14. Withdrug infusion along the wall 34 of the abdominal aorta 10, otherbranches extending from the abdominal aorta 10 cannot disturb the flowstreams into the renal arteries 12, 14.

Referring now to FIG. 15 and FIG. 16, a further embodiment is a druginfusion catheter with positioning struts for positioning the catheterwithin an abdominal aorta is shown and is generally designated 150. FIG.15 and FIG. 16 shows that the drug infusion catheter 150 includes anouter tube 152 that defines a proximal end (not shown) and a distal end154. A central support tube 156 extends from within the outer tube 152beyond the distal end 154 thereof. A tip 158 is provided at the end ofthe central support tube 156.

FIG. 15 and FIG. 16 show that the drug infusion catheter 150 includes afirst collapsible strut 160 and a second collapsible strut 162 slidablydisposed within the outer tube 152. Each collapsible strut 162 includesa proximal end (not shown) and a distal end 164 and the distal end 164of each collapsible strut 162 is attached to the tip 158. As intended bythe present embodiment, when each collapsible strut 160, 162 is extendedout of the outer tube 152, they bow outward relative to the centralsupport tube 156—since the distal end 164 of the strut 160, 162 isaffixed to the tip 158.

As shown, each collapsible strut 160, 162 includes an infusion port 166.Further, each collapsible strut 160, 162 includes a first marker band168 above the infusion port 166 and a second marker band 170 below theinfusion port 166. Preferably, each marker band is radio-opaque toassist in positioning the drug infusion catheter 150 within theabdominal aorta 10.

FIG. 15 shows the drug infusion catheter 150 in the collapsedconfiguration, i.e., with the collapsible struts 160, 162 that formpositioning struts in the collapsed configuration. In the collapsedconfiguration, the drug infusion catheter 150 can be inserted into tothe right or left iliac artery 22, 24 (FIG. 1) and fed into theabdominal artery 10 until it is in proper position near the renalarteries 12, 14. Once in position near the renal arteries 12, 14, thecollapsible struts 160, 162 can be advanced forward relative to theouter tube 152 causing them to release from the central support tube156. The collapsible struts 160, 162 can be advanced forward until theyestablish the expanded configuration shown in FIG. 16. In the expandedconfiguration, the infusion ports 166 are positioned immediatelyadjacent to the renal arteries 12, 14 and can release a drug solutiondirectly into the renal arteries 12, 14. It can be appreciated that thedrug infusion catheter 150 can be placed so that the drug solution isinfused immediately above the renal arteries 12, 14 along the wall 34 ofthe abdominal aorta 10. After a specified dwell time within theabdominal aorta 10, the drug infusion catheter 150 can be returned tothe collapsed configuration and withdrawn from the abdominal aorta 10.

Referring briefly to FIG. 17 and FIG. 18, another embodiment of a druginfusion catheter with positioning struts is shown. FIG. 17 and FIG. 18shows that the drug infusion catheter 150 can include a thirdcollapsible strut 172 and a fourth collapsible strut 174. Accordingly,when expanded as described above, the drug infusion catheter 150 withthe four collapsible struts 160, 162, 172, 174 resembles a cage.

FIG. 19 and FIG. 20 show another embodiment of a drug infusion catheterwith positioning struts for positioning the catheter within an abdominalaorta, generally designated 200. As shown, the drug infusion catheter200 includes an outer tube 202 having a proximal end (not shown) and adistal end 204. A first collapsible strut 206, a second collapsiblestrut 208, a third collapsible strut 210, and a fourth collapsible strut212 are established by the outer tube 202 immediately adjacent to thedistal end 204 of the outer tube 202. Moreover, a central supporthypotube 214 is slidably disposed within the outer tube 202. A distalend (not shown) of the central support hypotube 214 is affixed withinthe distal end 204 of the outer tube 202. Accordingly, as intended bythe present embodiment, when the central support hypotube 214 isretracted proximally in the outer tube 202, the struts 206, 208, 210,212 expand and create a cage configuration that can secure the druginfusion catheter 200, e.g., within the abdominal aorta 10 near therenal arteries 12, 14.

FIG. 19 and FIG. 20 show that the first strut 206 and the second strut208 are each formed with an infusion port 216. Additionally, a firstmarker band 218 is disposed above the infusion ports 216 along eachstrut. And, a second marker band 220 is disposed below the infusionports 216 along each strut. During use, a drug solution can be releasedfrom the infusion ports 216 formed in the first and second struts 206,208. It can be appreciated that the third and fourth struts 210, 212 canalso establish infusion ports and can further include marker bands, asdescribed above. It can also be appreciated that drug infusion catheter200 may be practiced with only a first and a second struts 206, 208 topresent a lower profile.

FIG. 19 shows the drug infusion catheter 200 in the collapsedconfiguration. In the collapsed configuration, the drug infusioncatheter 200 can be inserted into to the right or left iliac artery 22,24 (FIG. 1) and fed into the abdominal artery 10 until it is in properposition near the renal arteries 12, 14. Once in position near the renalarteries 12, 14, the central support hypotube 214 is retractedproximally in outer tube 202 causing the struts 206, 208, 210, 212 torelease from the central support tube 202 and bow outward. The centralsupport hypotube 214 can be retracted proximally, as described above,until the struts 206, 208, 210, 212 establish the expanded configurationshown in FIG. 20.

In the expanded configuration, the infusion ports 216 are positionedimmediately adjacent to the renal arteries 12, 14 and can release a drugsolution directly into the renal arteries 12, 14. It can be appreciatedthat the drug infusion catheter 200 can be placed so that the drugsolution is infused immediately above the renal arteries 12, 14 alongthe wall 34 of the abdominal aorta 10. After a specified dwell timewithin the abdominal aorta 10, the drug infusion catheter 200 can bereturned to the collapsed configuration and withdrawn from the abdominalaorta 10.

Referring to FIG. 21, another embodiment of a drug infusion catheterwith an anchor for positioning the catheter within an abdominal aorta isshown and is generally designated 250, FIG. 21 shows the drug infusioncatheter 250 installed within an abdominal aorta 10 in the vicinity ofthe renal arteries 12, 14. As shown in FIG. 21, the drug infusioncatheter 250 includes a central catheter tube 252 having a proximal end(not shown) and a distal end 254. A hollow stent 256 is attached to thedistal end 254 of the central catheter tube 252 and a drug solution canflow from the central catheter tube 252 into the hollow stent 256. Inthis aspect of the present embodiment, the hollow stent 256 is formedpartially or entirely of hollow hypo tubing, though other variations ofelastomeric tubing may be used.

As shown in FIG. 22 and FIG. 23, the stent 256 can be punctured orotherwise formed with plural infusion ports 258 along the outer surfaceof the stent 256. The drug infusion catheter 250 can be positioned, andexpanded, within the abdominal aorta 10, as shown in FIG. 21, such thatthe stent 256 is anchored in the vicinity of the renal arteries 12, 14.As such, a drug solution can be released from the hollow stent 256 viathe infusion ports 258 directly into the renal arteries 12, 14. Byexpanding the stent 256 against the inner wall 34 of the abdominal aorta10 in the area of the renal arteries 12, 14 all the infusion ports canbe blocked (since they are established on the outside surface of thestent 256) except those that are directly over the renal ostia. Thus,when a drug solution is infused, its flow into the renal arteries 12, 14is maximized.

It can be appreciated that the stent 256 can form an expandableopen-mesh structure that can have an element, or a few elements, thatcross the renal ostia without disrupting the blood flow to the renalarteries 12, 14. It is to be understood that the ability to deploy andrecapture the stent 256 can be accomplished using a number of methodsapparent to those of ordinary skill in the art based on review of thisdisclosure, e.g., by suitably modifying the methods typically employedfor deploying and recapturing temporary vena cava filters or retractablestents.

Referring now to FIG. 24 through FIG. 28, another embodiment of a druginfusion catheter with positioning loops for positioning the catheterwithin an abdominal aorta is shown and is generally designated 300. FIG.24 through FIG. 28 show that the drug infusion catheter 300 includes acentral catheter tube 302 that defines a proximal end (not shown) and adistal end 304. As shown, a generally vertically oriented positioningloop 306 extends from the distal end 304 of the central catheter tube302. Preferably, the positioning loop 306 is made from a memory metal,e.g., nickel-titanium (NiTi). It is to be understood that thepositioning loop 306 can be held in a pre-determined position via shapesetting or it can be in a free-form shape and held in a final diametervia the inner wall 34 of the abdominal aorta 10. As specifically shownin FIG. 26 and FIG. 27, the positioning loop 306 can sufficiently holdthe drug infusion catheter 300 in place regardless of the diameter ofthe abdominal aorta 10 e.g. as shown in the smaller and larger diameteraortas of FIG. 26 and FIG. 27, respectively.

As shown in FIG. 24 through 28, the drug infusion catheter 300 caninclude a pull wire 308 that extends from a port 310 formed in thecentral catheter tube 302. The pull wire 308 is attached to thepositioning loop 306 and can be used to control the expansion andcontraction of the positioning loop 306 without the need for an externalsheath. FIG. 28 specifically shows the positioning loop 306 in a fullyretracted configuration that can be used when inserting or withdrawingthe drug infusion catheter 300.

FIG. 24 through 28 further show that the central catheter tube 302 isformed with a first infusion port 312 and a second infusion port 314. Adrug solution can exit the central catheter tube 302 and flow into therenal arteries 12, 14 as indicated by arrow 316 and 318.

It can be appreciated that the drug infusion catheter 300 shown in FIG.24 through 28 can allow rotational position adjustment and verticalposition adjustment without the risk of trauma to the abdominal aorta10. Further, the positioning loop 306 can be retracted numerous ways toallow atraumatic rotation. And, since there are not any protruding ortraumatic edges to catch aortic tissue on, the drug infusion catheter300 can be moved up and down without retracting the positioning loop306. In another beneficial embodiment, positioning loop 306 is free formwithout pull wire 310. It can be appreciated that positioning loop 306can be made of a shape-memory alloy, such as Nitinol™, and advancedthrough the distal end 304 of catheter 300 for positioning and retractedfor insertion and removal.

The present embodiment recognizes that experimental observations haveshown that a drug solution can flow into the renal arteries 12, 14naturally, provided the drug infusion is undertaken above the renalarteries 12, 14 and above or closely adjacent to the posterior aspect ofthe inner wall 34 of the abdominal aorta 10. As shown in FIG. 25 throughFIG. 28, the positioning loop 306 can easily position the centralcatheter tube 302 against the posterior of the inner wall 34 of theabdominal aorta 10 and does not require a flow diverter, e.g., a balloonor membrane, to maximize drug infusion to the renal arteries 12, 14. Assuch, the possibility of thrombus formation due to the disruption ofblood flow is minimized.

It can be appreciated that the drug infusion catheter 300 can easilyallow various guide catheters and guide wires to pass therethrough andthat passage can have minimal effect on the tactile feedback or otherperformance aspects of the adjunctive catheters that are typically usedin a percutaneous coronary intervention (PCI).

FIG. 29 shows another embodiment of a drug infusion catheter with apositioning loop for positioning the catheter within an abdominal aorta,generally designated 330. As shown, the drug infusion catheter 330includes a central catheter tube 332 having a proximal end (not shown)and a distal end 334. As shown, a positioning loop 336 extends from thedistal end 334 of the central catheter tube 332. Further, the druginfusion catheter 330 can include a pull wire 338 that extends from aport 340 formed in the central catheter tube 332. The pull wire 338 isattached to the positioning loop 306 and can be used to retract thepositioning loop 336 during insertion or withdrawal of the drug infusioncatheter 330.

As shown in FIG. 29, a flow director 342 is affixed to the distal end334 of the central catheter tube 332. The flow director 342 is formedwith a bifurcated (e.g. a T-shaped) infusion passage 344 that directsthe flow of a drug solution from an infusion port (not shown) formed inthe distal end 334 of the central catheter tube 332 in two opposingdirections—as indicated by arrow 346 and arrow 348.

Referring to FIG. 30 and FIG. 31, another embodiment of a drug infusioncatheter with positioning loops for positioning the catheter within anabdominal aorta is shown and is generally designated 360. As shown, thedrug infusion catheter 360 includes a central catheter tube 362 thatdefines a proximal end (not shown) and a distal end 364. As shown, afirst positioning wire 366 and a second positioning wire 368 extend froma port 370 formed in the central catheter tube 362. Each positioningwire 366, 368 defines a proximal end (not shown) and a distal end 372.The distal end 372 of each positioning wire 366, 368 is attached to thedistal end 364 of the central catheter tube 362. It is to be understoodthat the positioning wires 366, 368 extend through the entire length ofthe central catheter tube 370 and can be used to establish an adjustablepositioning loop. It can be appreciated that the adjustable positioningloop can be adjusted by extending or retracting the positioning wires366, 368 through the port 370 in the central catheter tube 363.

Referring now to FIG. 32 and FIG. 33, one embodiment of a drug infusioncatheter with a renal flow isolator is shown and is generally designated400. As shown, the drug infusion catheter 400 includes a centralcatheter tube 402 that defines a proximal end (not shown) and a distalend 404. A ring 406 is attached to the distal end 404 of the centralcatheter tube 402. Moreover, a generally cylindrical curtain 408 extendsfrom the ring 406. Preferably, in this aspect of the present invention,the curtain 408 is made from expanded polytetrafluoroethylene (ePTFE) orany material with similar characteristics well known in the art. In onebeneficial embodiment, the overall length of renal flow isolator 400 isabout 1.5 cm.

FIG. 32 and FIG. 33 further show an infusion tube 410 that extendsbi-directionally from the central catheter tube 402. A first infusionport 412 and a second infusion port 414 are established on the outsideof curtain 408 by the infusion tube 410. In the exemplary, non-limitingembodiment shown in FIG. 32 and FIG. 33, the single ring 406 allows forsizing to the abdominal aorta 10 to maintain the infusion ports 412, 414along the inner wall 34 of the abdominal aorta 10. It can be appreciatedthat the configuration of the drug infusion catheter 400 shown in FIG.32 and FIG. 33 reduces the amount of stagnant blood around the druginfusion catheter 400 and thereby, minimizes the blood clotting thereon.This configuration also puts the drug along the aortic wall. In oneembodiment, central catheter tube 402 has an offset that is a slight Sshape (not shown) and positions renal flow diverter 400 off the aortawall.

FIG. 34 and FIG. 35 show a further embodiment of a drug infusioncatheter with a flow isolator, generally designated 430. As shown, thedrug infusion catheter 430 includes a central catheter tube 432 with amid distal position 433 and a distal end 434. An upper ring 436 isattached to the distal end 434 of the central catheter tube 432.Moreover, a lower ring 438 is attached to the catheter tube 432 at middistal position 433 and at a distance slightly spaced from the upperring 436. FIG. 34 and FIG. 35 further show catheter tube 432 connectingthe upper ring 436 to the lower ring 438. In this aspect of the presentinvention, the catheter tube 432 between mid distal position 433 anddistal end 434 is covered with a layer of fabric 440, such as ePTFE,extending from upper ring 436 to lower ring 438. It can be appreciatedthat the orientation of fabric 440 reduces the amount of stagnant bloodcollecting around the drug infusion catheter 430 and thereby, minimizesthe blood clotting thereon. In one beneficial embodiment, the overalllength of drug infusion catheter is about 2 cm.

As shown in FIG. 34 and FIG. 35, a first infusion port 442 and a secondinfusion port 444 are established in a mid section of fabric 440 of thedrug infusion catheter 430. It is to be understood that the upper ring436 and the lower ring 438 ensure that the infusion ports 442, 444 areplaced along side of the inner wall 34 of the abdominal aorta 10. Thepreferred position of the drug infusion catheter 430 within theabdominal aorta 10 is such that the infusion ports 442, 444 are closestto the posterior of the abdominal aorta 10. Moreover, the rings 436 and438 do not significantly alter blood flow through the abdominal aorta 10and since they are open, a guiding catheter (not shown), or any otherworking catheter, can be advanced through the drug infusion catheter430. In one embodiment, central catheter tube 432 has an offset that isa slight S shape (not shown) and positions drug infusion catheter 430off the aorta wall.

Referring to FIG. 36 through FIG. 38, another embodiment of a druginfusion catheter is shown and is generally designated 460. As shown,the drug infusion catheter 460 includes a central catheter tube 462 thatdefines a proximal end (not shown) and a mid distal position 464. A ring466 is attached near the mid distal position 464 of the catheter tube462.

FIG. 36 through FIG. 38 further show central catheter tube 462 with anoffset near mid distal position 464 and a sail 470 attached to thedistal end 468 that extends partially around the perimeter of the ring466. It can be appreciated that the sail 470 forms a semi-conical shapebetween the mast 468 and the ring 466. In this aspect, the sail 470 ismade from ePTFE, though other suitable materials may be used or applied.It can be appreciated that the semi-conical shape of the sail 470 andthe material from which it is constructed reduces the amount of stagnateblood around the drug infusion catheter 460 and as such, the chance ofblood clots forming around the drug infusion catheter 460 is minimized.FIG. 36 and FIG. 38 show a first infusion port 472 and a second infusionport 474 established along the catheter tube 462 between distal end 468and ring 466.

As intended by the present embodiment, the ring 466 maintains theposition of the drug infusion catheter 460 against the inner wall 34 ofthe abdominal aorta 10. Also, the sail 470 is designed to divert bloodflow, and thus, the flow of a drug solution trickling from the infusionports 472, 474, into the renal arteries 12, 14. The preferred positionof the drug infusion catheter 460 within the abdominal aorta 10 is suchthat the infusion ports 472, 474 are closest to the posterior of theabdominal aorta 10.

FIG. 39 shows one embodiment a drug infusion guide catheter, designated500, that can be placed within an abdominal aorta 10 in the generalvicinity just above the renal arteries 12, 14. As shown, the druginfusion guide catheter 500 includes an infusion port 502 formed in theouter wall of the drug infusion guide catheter 500. It can beappreciated that a drug solution can be released from the drug infusionguide catheter 500 via the infusion port 502. The renal blood flow (seeFIG. 2) to each renal artery 12, 14 is about 15 percent of total aorticblood flow for a total of about 30 percent. With no change in bloodflow, about 30 percent of drug solution released from infusion port 502will reach renal arteries 12,14.

It is to be understood that it is most advantageous to release the drugsolution from the drug infusion guide catheter 500 during systole, asindicated by arrow 504 and arrow 506. As shown in FIG. 39, duringsystole, the drug solution can flow in a generally downward directionfrom the infusion port 502, as indicated by arrow 508 and arrow 510, andinto the right renal artery 12 and the left renal artery 14, asindicated by arrow 512 and arrow 514. It is to be further understoodthat the drug infusion guide catheter 500 is at least formed with twolumens therein, i.e., a first relatively larger lumen for the exchangeof devices and a second relatively smaller lumen for drug infusion.Accordingly, as intended by the present embodiment, the requirement fora secondary device, in addition to the drug infusion guide catheter 500,to infuse drugs and medication to the renal arteries 12, 14 during a PCIis obviated.

FIG. 40 shows another embodiment of a drug infusion guide catheter,generally designated 520. As shown, the drug infusion guide catheter 520can be inserted into the abdominal aorta 10, e.g., via the left or rightiliac artery 22, 24 (FIG. 1), until it is in the vicinity of the renalarteries 12, 14. FIG. 40 shows that the drug infusion guide catheter 520includes an infusion port 522 that is formed in the outer wall of thedrug infusion guide catheter 520. It can be appreciated that a drugsolution can be released from the drug infusion guide catheter 520 viathe infusion port 522. As shown in FIG. 40, the drug infusion guidecatheter 520 further includes a balloon 524 that can be inflated todivert blood flow into the renal arteries 12, 14.

In this aspect of the present invention, the balloon 524 can be madefrom silicon, nylon, PEBAX, polyurethane, or any other similar compliantor semi-compliant material well known in the art. Moreover, the balloon524 can be inflated such that it engages the inner wall 34 of theabdominal aorta 10 or it can be inflated such that it is smaller thanthe diameter of the inner wall 34 of the abdominal aorta 10 so that itwill not entirely block the flow of blood through the abdominal aorta10. Basically, the size of the balloon 524 can be easily varied byvarying the inflation pressure of the balloon 524 thereby affecting theblood flow past renal arteries 12, 14.

It is to be understood that the drug infusion guide catheter 520 shownin FIG. 40 is preferably formed with three lumens therein. For example,the drug infusion guide catheter 520 can include a first relativelylarge lumen for the exchange of devices, a second relatively small lumenfor drug infusion, and a third relatively small lumen for ballooninflation.

As previously stated above, it is beneficial to release a drug solutionin the abdominal aorta 10, e.g., from the drug infusion guide catheter520, during systole, as indicated by arrow 526 and arrow 528. Duringsystole, the drug solution can flow in a generally downward directionfrom the infusion port 522, as indicated by arrow 530 and arrow 532, andinto the right renal artery 12 and the left renal artery 14, asindicated by arrow 534 and arrow 536. It can be appreciated that theballoon 524 maximizes the flow of the drug solution into the renalarteries 12, 14. Per this embodiment, a counter pulsation of the balloonrelative to the systolic/diastolic cycle may be used to enhanceperformance.

Referring now to FIG. 41 and FIG. 42, another embodiment of a druginfusion guide catheter is shown and is generally designated 550. Asshown, the drug infusion guide catheter 550 can be advanced into theabdominal aorta 10, e.g., via the left or right iliac artery 22, 24(FIG. 1), until it is in the vicinity of the renal arteries 12, 14. FIG.41 shows that the drug infusion guide catheter 550 includes an infusionport 552 that is formed in the outer wall of the drug infusion guidecatheter 550. It can be appreciated that a drug solution can be releasedfrom the drug infusion guide catheter 550 via the infusion port 552. Asshown in FIG. 41, the drug infusion guide catheter 550 further includesa flow diverter 554 that can be expanded to divert blood flow into therenal arteries 12, 14.

FIG. 41 shows that the flow diverter 554 includes a membrane 556 thatcan be expanded by a frame 558—much like a basket or an umbrella. Inthis aspect of the present invention, the membrane 556 can be made fromnylon, PEBAX, polyurethane, low density PTFE or any other similarmaterial with low porosity to allow for blood diffusion through themembrane 556. Moreover, the membrane 556 can be lazed or otherwiseformed with plural holes 560 of varying diameter, e.g., from twenty-fivemicrometers to five-hundred micrometers (25 μm-500 μm) to allow bloodflow through the material film. In another embodiment, membrane 556 canbe a wire mesh or stent-like devices. Further, the frame 558 ispreferably made from a memory metal, e.g., NiTi, to allow forconformability to the aorta and pre-shaped capabilities. It can beappreciated that the flow diverter 554 can be expanded such that itengages the inner wall 34 of the abdominal aorta 10.

Referring briefly to FIG. 42, it is shown that the flow diverter 554 canbe collapsed within an outer sheath 562 disposed around the druginfusion guide catheter 550. Once the drug infusion guide catheter 550is in place within the abdominal aorta 10, the sheath 562 can bewithdrawn causing the flow diverter 554 to be deployed near the renalarteries 12, 14.

It is to be understood that the drug infusion guide catheter 550 shownin FIG. 41 is preferably formed with at least two lumens therein. Forexample, the drug infusion guide catheter 550 can include a firstrelatively large lumen for the exchange of devices, and a secondrelatively small lumen for drug infusion.

As previously stated above, it is most beneficial to release a drugsolution in the abdominal aorta 10, e.g., from the drug infusion guidecatheter 550, during systole, as indicated by arrow 564 and arrow 566shown in FIG. 41. During systole, the drug solution can flow in agenerally downward direction from the infusion port 552, as indicated byarrow 568 and arrow 570, and into the right renal artery 12 and the leftrenal artery 14, as indicated by arrow 572 and arrow 574. It can beappreciated that the flow diverter 554, when deployed, maximizes theflow of the drug solution into the renal arteries 12, 14.

Referring to FIG. 43 and FIG. 44, an embodiment of a guide catheter witha coaxial drug infuser is shown and is generally designated 600. FIG. 43shows that the guide catheter with a coaxial drug infuser 600 includes acentral catheter tube 602 around which a generally ring shaped, druginfuser 604 is slidably disposed. A drug infusion catheter 606 extendsfrom the drug infuser 604 and can be used to supply a drug solution tothe drug infuser 604. FIG. 44 shows that an annular space can beestablished between the drug infuser 604 and the central guide catheter602. An infusion port (not shown) can be established in drug infuser604, and is fluidly connected to drug infusion catheter 606.

FIG. 43 shows that a drug solution can exit the drug infuser 604 via thetop of the drug infuser 604, as indicated by arrow 610 and arrow 612.The drug solution can also exit the drug infuser 604 at the bottom ofthe drug infuser 604, as indicated by arrow 614 and arrow 616. In oneembodiment, the bottom of drug infuser 604 fits closely around centralcatheter tube 602 and drug solution flows preferably out the top asshown by arrow 610, 612. In another embodiment, the top of drug infuser604 fits closely around central catheter tube 602 and drug solutionflows preferably out the bottom as shown by arrow 614, 616 Duringsystole, indicated by arrow 618 and arrow 620, the drug solution canflow into the right and left renal arteries 12, 14, as indicated byarrow 622 and arrow 624. When positioned below renal arteries 12, 14(not shown) drug infuser 604 provides drug solution preferentially tothe lower extremities. While a ring shape is shown, other embodiments,e.g. a partial ring, are contemplated for slideable coupling forindependent positioning.

Referring now to FIG. 45, another embodiment of a guide catheter with acoaxial drug infuser is shown. As shown, the guide catheter with acoaxial drug infuser is identical to the embodiment shown in FIG. 43 andFIG. 44. However, the guide catheter with a coaxial drug infuser shownin FIG. 45 further includes a balloon 626 fluidly connected to the druginfusion catheter 606. The balloon 626 can be inflated to divert theflow of blood therearound and further increase the flow of the drugsolution into the renal arteries 12, 14.

FIG. 46 shows a catheter assembly with a drug infusion introducersheath, generally designated 640. As shown, the catheter assembly 640includes a central guide catheter 642 that is inserted through the rightiliac artery 22 and advanced until it is within the abdominal aorta 10.FIG. 46 further shows a drug infusion introducer sheath 644 around thecentral guide catheter 642. The drug infusion introducer sheath 644defines a proximal end 646 and a distal end 648. As shown, the proximalend 646 of the introducer sheath 644 is attached to a catheterintroducer hub 650 that can be used to advance the introducer sheath 644into aorta 10. Preferably, the drug infusion introducer sheath 644 canbe advanced until the distal end 648 of the introducer sheath 644 is ator above the renal arteries 12, 14.

Further, as shown in FIG. 46, an annular infusion port 652 isestablished between the central guide catheter 642 and the drug infusionintroducer sheath 644. A drug solution can flow in the space between thecentral guide catheter 642 and the drug infusion introducer sheath 644and exit through the annular infusion port 652 at or above the renalarteries 12, 14. The drug solution can then flow into the right renalartery 12, as indicated by arrow 654 and arrow 656. Moreover, the drugsolution can flow into the left renal artery 14 as indicated by arrow658 and arrow 660. It can be appreciated that the drug solution can besupplied to the drug infusion introducer sheath 644 via a drug infusiontube 662 connected to the catheter introducer hub 650. While an annularinfusion port 652 is shown, other shapes for an infusion port may becontemplated.

In a beneficial embodiment, a standard catheter introducer sheath,usually 8-23 cm in length (not shown), is replaced with a longercatheter introducer sheath 644 that can reach the renal arteries. Alonger sheath, 40-60 cm in length, depending on patient height andvascular tortuousity, is used in lieu of the standard catheterintroducer sheath, and its distal tip is placed at a level slightlyabove the renals, preferably at or below the level of the superiormesenteric artery (SMA). The drug desired to be infused selectively intothe renal arteries is infused through the catheter introducer sheathwhile the coronary procedure is performed. This is a marked improvementover systemic infusion of a drug solution since the flow to the renalarteries 12, 14 is about 30 percent of total aortic blood flow.

Referring to FIG. 47 a catheter assembly with an infusion or “weeping”balloon is shown and is generally designated 700. As shown, the catheterassembly 700 includes a central catheter tube 702 that is insertedthrough the right iliac artery 22 and advanced until it is within theabdominal aorta 10. FIG. 47 shows a drug infusion balloon 704 mountedmid-shaft on the central catheter tube 702. As shown, a catheterintroducer hub 706 can be used to advance the central catheter tube 702into the abdominal aorta 10. Preferably, the central catheter tube 702can be advanced until the drug infusion balloon 704 is in the vicinityof the renal arteries 12, 14. In another beneficial embodiment, centralcatheter tube is advanced into the aorta system through an introducersheath system (not shown). It is understood that central catheter tube702 may have one or more lumens for drug solution delivery.

FIG. 47 shows that the drug infusion balloon 704 is formed with pluralinfusion ports 708. The infusion ports 708 are small enough to allow forpressure to be built up inside the drug infusion balloon 704.Additionally, the infusion ports 708 allow for a slow infusion of theinflating fluid, e.g., a drug solution, into the vascular system inwhich the drug infusion balloon 704 is placed, e.g., within theabdominal aorta 10.

In a beneficial embodiment, the central catheter tube 702 is advancedinto the abdominal aorta 10 until the drug infusion balloon 704 is inthe peri-renal aorta. The drug infusion balloon 704 is then inflatedsuch that the drug infusion balloon 704 partially covers the renalarteries 12, 14. Some of the infusion ports 708 formed in the druginfusion balloon 704 can be pressed against the inner wall 34 of theabdominal aorta 10 and accordingly, be blocked thereby. Other infusionports 706 in proximity to the renal arteries 12, 14 can be unblocked. Adrug solution can be supplied to the drug infusion balloon 704 via thecentral catheter tube 702. A drug infusion tube 710 is connected to thecatheter introducer hub 706 and supplies the drug solution to thecentral catheter tube 702. Since the drug solution can flow through theunblocked infusion ports 708, as indicated by arrow 712 and arrow 714,the delivery of the drug solution to the renal arteries 12, 14 ismaximized.

It is to be understood that the catheter system 700 described in detailabove can further include an intake (not shown) above the drug infusionballoon 704. Thus, blood can flow into the drug infusion balloon 704 andpre-mix with the drug solution within the drug infusion balloon 704prior to delivery to the renal arteries. Additionally, it can beappreciated that the catheter system 700 described above can be anindividual system or it can be incorporated with another interventionaldevice, i.e., mounted on a guiding catheter.

Referring now to FIG. 48 through FIG. 50 a self-shaping drug infusioncatheter is shown and is generally designated 720. The self-shaping druginfusion catheter 720 includes a proximal end (not shown) and a distalend 722. FIG. 48 shows the self-shaping drug infusion catheter 720installed over a guide wire 724. In one embodiment, the self-shapingdrug infusion catheter 720 is made from a memory metal, e.g., NiTi, anda standard polymer. It is to be understood that the memory metal can bebraided or coiled around a polymer tube. In another mode, the memorymetal can be present in the polymer tube via a mandrel or a spine whichruns the length of the self-shaping drug infusion catheter 720. Thememory metal can be shape set to create the preferred free state shapeof the self-shaping drug infusion catheter 720, described below.

Accordingly, as intended by the present embodiment, the self-shapingdrug infusion catheter 720 can remain straight and highly flexible withthe guide wire 724 installed therein. However, when the guide wire 724is withdrawn, or otherwise retracted, from within the self-shaping druginfusion catheter 720, the self-shaping drug infusion catheter 720returns to its free state shape. It can be appreciated that theself-shaping drug infusion catheter 720 can also return to its freestate shape via a thermal response—if necessary.

In a beneficial embodiment, shown in FIG. 49 and FIG. 50, the free stateshape of the self-shaping drug infusion catheter 720 is a generallyspiral shape. Moreover, the self-shaping drug infusion catheter 720 ispreferably formed with plural infusion ports 726. When the self-shapingdrug infusion catheter 720 is in its free state shape, i.e., the spiralshape, the infusion ports 726 are located on the outside of the spiral.In another beneficial embodiment, the spiral shape can extend about 1inch to about 2 inches in length.

FIG. 49 and FIG. 50 show the self-shaping drug infusion catheter 720installed in an abdominal aorta 10. It can be appreciated that theself-shaping drug infusion catheter 720 can be inserted in the leftiliac artery 24 and advanced therethrough until the distal end 722 ofthe drug infusion catheter 720 is in the general vicinity of the renalarteries 12, 14. As described above, when the guide wire 724 (FIG. 48)is withdrawn, the self-shaping drug infusion catheter 720 returns to itsfree shape, i.e., the spiral shape, such that the outer periphery of theself-shaping drug infusion catheter 720 is placed and somewhat pressedagainst the inner wall 34 of the abdominal aorta 10.

In the juxta-renal position, shown in FIG. 49 and FIG. 50, a majority ofthe infusion ports 726 established around the outer periphery areblocked by the inner wall 34 of the abdominal aorta 10. Several of theinfusion ports 726, located at the renal ostia, are not blocked and canallow the flow of a drug solution into the right renal artery 12 and theleft renal artery 14, as indicated by arrow 728 and arrow 730. By way ofexample and not of limitation, the infusion ring pressed against theaortic wall will not flow drugs under the very low infusion rates andpressures expected, i.e. approaching 1 ml per minute from an IV pole.However the infusion ring will flow drugs where they are free and not incontact with the aorta wall at the renal ostia. FIG. 49 shows that asecond working catheter 732 can be introduced through the middle of theself-shaping drug infusion catheter 720 when it is in the free statespiral shape.

FIG. 51 shows a self-shaping drug infusion catheter assembly generallydesignated 750 in which the self-shaping drug infusion catheter 720 andthe working catheter 732 can be incorporated. As shown in FIG. 51, theself-shaping drug infusion catheter assembly 750 includes a Y hubassembly 752 through which the self-shaping drug infusion catheter 720and the working catheter 732 can be introduced, and introducer sheath754. It is to be understood that the overall length of the introducersheath 754 shown in FIG. 51 can be relatively shorter than typicalintroducers used for tubular member flow diverters. This is largely dueto the fact that the self-shaping drug infusion catheter 732 can be usedto access the area of the renal arteries 12, 14, whereas otherintroducers may use an additional delivery sheath for this purpose.Further, the Y-hub assembly 752 shown in FIG. 51 can allow twocatheters, e.g., the self-shaping drug infusion catheter 720 and theworking catheter 732, to be placed, e.g., in the femoral artery througha single percutaneous cut-down. Also, the Y-hub assembly 752 providesadequate hemostasis and overall tactile feedback and control of thecatheters used in conjunction therewith.

FIG. 52 is a side view, and FIG. 53 a section view of another embodimentof a catheter system 760 with a multilumen sheath 762 having a distalend 764 and a proximal end 766. In FIG. 53, sheath 762 has center lumen768, left lumen 770 and right lumen 772. A guide catheter 774, having adistal portion 776 and a proximal end 778 is inserted in center lumen768. In one exemplary mode, guide catheter 774 is about 6 French indiameter.

In FIG. 52, proximal end 766 of sheath 762 is attached to a Y hubassembly 780. The illustration of Y hub assembly 780 is stylized forclarity. Y hub assembly 780 has left branch port 782 right branch port784 and main port 786. Left fluid delivery tube 788 has proximal portion790 and distal portion 792 with proximal portion 790 inserted in leftbranch port 782 and fluidly connected with distal portion 792 throughleft lumen 770. Right fluid delivery tube 794 has proximal portion 796and distal portion 798 with proximal portion 790 inserted in rightbranch port 784 and fluidly connected with distal portion 798 throughright lumen 772. Proximal end 778 of guide catheter 774 is inserted inmain port 786 of Y hub assembly 780 and is connected to distal portion776 through center lumen 768. Distal end of sheath 762 has left port 800in left lumen 770 and right port 802 in right lumen 772. In oneembodiment, left port 800 and right port 802 are 180 degrees apart.Distal portion 792 of left fluid delivery tube 788 has a memory shape toextend out of left port 800 when advanced in sheath 762 and has mid port804 and end port 806. Distal portion 798 of right delivery tube 794 hasa memory shape to extend out of right port 802 when advanced in sheath762 and mid port 808 and end port 810.

In FIG. 52, sheath 762 has been inserted in aorta 10, shown in FIG. 1,and distal end 764 of sheath 762 is positioned upstream of renalarteries 12,14. Left and right fluid delivery tubes 788, 794 areadvanced through left port 782 and right port 784 so distal ends 792,798 extend towards left and right walls of aorta 10 respectively. Fluidagent, denoted by arrows 812, is released from mid ports 804, 808 andfrom end ports 806, 810 to preferentially flow into renal arteries12,14. Guide catheter 774 is advanced through main port 786 of Y hubassembly 780 with distal portion 776 extending beyond distal end 764 ofsheath 762 for further medical procedures.

FIG. 54 through FIG. 57 illustrates an embodiment of a proximal couplersystem 850 used to deploy and position renal fluid delivery devicesadjunctive with interventional catheters. FIG. 54 and FIG. 55 illustratea proximal coupler system 850 in side view, and cut away section view. YHub body 852 is configured with an introducer sheath fitting 854 at thedistal end 856 of hub body 852 and a main adapter fitting 858 at theproximal end 860 of Y hub body 852. Main branch 862 has tubular mainchannel 864 aligned on axis 866. Main channel 862 fluidly connectsintroducer sheath fitting 854 and main adapter fitting 858. By way ofexample and not of limitation, one embodiment of main channel 864 isadapted to accommodate a 6 Fr guide catheter. Side port fitting 868 ispositioned on main branch 862 and is fluidly connected to main channel864. Secondary branch 870 has tubular branch channel 872 that intersectsmain channel 864 at predetermined transition angle β. In one beneficialembodiment, transition angle β is approximately 20 degrees. Proximal end874 of secondary branch 870 has secondary fitting 876. In one beneficialembodiment, a channel restriction 878 is molded into introducer sheathfitting 854. Y hub body 852 may be molded in one piece or assembled froma plurality of pieces.

FIG. 56A and FIG. 56B illustrate a proximal coupler system 850 with ahemostasis valve 880 attached at main port 858 and Touhy Borst valve 882attached at branch port 876. Fluid tube 884 is coupled to side port 868and fluidly connects stop valve 886 and fluid port 888. Introducersheath 890 with proximal end 892 and distal end 894 is coupled to Y hubbody 852 at Sheath fitting 854. Proximal coupler system 850 is coupledto a local fluid delivery system 900. A stiff tube 902, has a distal end904 (shown in FIG. 56B), a mid proximal section 906, and a proximal end908. In one embodiment, stiff tube 902 is made of a Nickel-Titaniumalloy. Stiff tube 902 is encased in delivery sheath 910 distal of midproximal section 906. By way of example and not of limitation, deliverysheath 910 may be about 6 Fr to about 8 Fr in diameter. A torque handle912 is coupled to stiff tube 902 at a mid proximal position 906. Amaterial injection port 916 is positioned at the proximal end 908 ofstiff tube 902. Material injection port 916 is coupled to an adaptervalve 920 for introducing materials such as fluids. Side port fitting922 is coupled to tube 924 and further coupled to stopcock 926 and fluidfitting 928. In an exemplary embodiment, adaptor 920 is a Luer valve. Inanother exemplary embodiment, side port fitting 922 is used forinjecting a saline solution. Delivery sheath handle 930 is positionedand attached firmly at the proximal end 932 of delivery sheath 910.Delivery sheath handle 930 has two delivery handle tabs 934. In anexemplary embodiment, delivery sheath handle 930 is configured to breaksymmetrically in two parts when delivery handle tabs 934 are forcedapart.

In FIG. 56B, Delivery sheath 910 is inserted through Touhy Borst adapter882 through secondary branch channel 872 until distal end (not shown) ofdelivery sheath 910 is against channel restriction 878 (see FIG. 55). Atthat point, force 940 is applied in a distal direction at torque handle912 to push stiff tube 902 through delivery tube 910. A fluid agentinfusion device 936 on distal end 904 of stiff tube 902 is adapted toadvance distally through introduction sheath 890. In FIG. 56B, stifftube 602 has been advanced through introduction sheath 890 and past thedistal end 894 of introduction sheath 890. Optionally, delivery sheathhandle 930 is split in two by pressing inwardly on delivery handle tabs934. Delivery sheath 910 may be split by pulling delivery tabs 934 apartand retracted from Y hub assembly 852 through Touhy Borst adapter 882 toallow a medical intervention device (shown in FIG. 57) to enterhemostasis valve 880 for further advancement through main channel 864(see FIG. 55) and adjacent to stiff tube 902.

FIG. 57 is an illustration of the proximal coupler system 850 of FIG.56B with introducer sheath 890 is inserted in aorta system 10. Deliverysheath 910 has been retracted proximally and one or more fluid agentinfusion devices 936 have been advanced and positioned at renal arteries12,14. Intervention catheter 940 enters hemostasis valve 880 and isadvanced through introducer sheath 890 and past fluid agent infusiondevice 936 for further medical intervention while fluid agent infusiondevice 936 remains in place at renal arteries 12,14. It is to beunderstood that proximal coupler systems can be further modified withadditional branch ports to advance and position more than two devicesthrough a single introducer sheath.

FIG. 58 illustrates a further embodiment of the proximal couplerassembly and fluid delivery assembly shown in FIG. 57. Renal therapysystem 950 includes an introducer sheath system 952, a vessel dilator954 and a fluid delivery system 956 with a aortic infusion assembly 958.Details of channels, saline systems and fittings as shown previously inFIG. 54 through FIG. 57 are omitted for clarity. Introducer sheathsystem 952 has Y hub body 960 as shown previously in FIG. 54 and FIG. 55configured various inner structures as shown previously in FIG. 55. Yhub body 960 has hemostasis valve 962 on proximal end 966 and TouhyBorst valve 968 on secondary end 970. Distal end 972 of Y hub body 960is coupled to proximal end 974 of introducer sheath 976. Introducersheath 976 has distal tip 978 that has a truncated cone shape andradiopaque marker band 980. In one embodiment, introducer sheath 976 isconstructed with an inner liner of PTFE material, an inner coiled wirereinforcement and an outer polymer jacket. Introducer sheath 976 haspredetermined length L measured from proximal end 974 to distal tip 978.

Vessel dilator 954, with distal end 980 and proximal end 982 is apolymer, (e.g. extrusion) tubing with a center lumen for a guide wire(not shown). Distal end 980 is adapted with a taper cone shape. Proximalend 982 is coupled to a Luer fitting 984.

Fluid delivery system 956 has stiff tube 986, torque handle 988, andproximal hub 990 as previously described in FIG. 56A and FIG. 56B withaortic infusion assembly 958 coupled at distal end 992. The proximal hub990 of fluid delivery system 956 has a Luer fitting 1002 for infusing afluid agent, and is fluidly coupled with the stiff tube 986.

A single lumen, tear-away delivery sheath 1004 has a distal end 1006, aproximal end 1008, and slidingly encases stiff tube 986. Delivery sheath1004 is positioned between the torque handle 988 and the bifurcatedcatheter 956. The distal end 1006 has a shape and outer diameter adaptedto mate with the channel restriction in the distal end of the mainchannel of the Y hub body as shown previously in FIG. 55. The proximalend 1008 of the delivery sheath 1004 is coupled to a handle assembly1010 with two handles 1012 and a tear away cap 1014.

Dilator 954 is inserted through Touhy Borst valve 968 on secondary port970 until distal end 980 protrudes from distal tip 978 of introducersheath 976 to form a smooth outer conical shape. Distal tip 978 ofintroducer sheath 976 is positioned in the aorta system near the renalarteries (not shown). Dilator 954 is removed and fluid delivery device956 is prepared by sliding delivery sheath 1004 distally until aorticinfusion assembly 958 is enclosed in delivery sheath 1004. Distal end1006 of delivery sheath 1004 is inserted in Touhy Borst valve 968 andadvanced to the restriction in the main channel of the Y hub body shownin FIG. 55. Aortic infusion assembly 958 is advanced distally intointroducer sheath 976. Tear away delivery sheath 1004 is retracted andremoved through Touhy Borst valve 968 as shown previously in FIG. 56B.Aortic infusion assembly 958 is advanced distally out of the distal tip978 of introducer sheath 976 and positioned to infuse fluid agent in therenal arteries as shown in FIG. 57.

FIG. 59 is a stylized illustration of a double Y proximal coupler 1150with two local fluid delivery systems 1152, 1154 and an interventioncatheter 1156 in an aorta system 10. Details of local fluid deliverysystems 1152, 1154 are shown in FIGS. 56A and 56B and are omitted herefor clarity. The double Y proximal coupler 1150 is constructed similarto a proximal coupler assembly as shown in FIG. 54 and FIG. 55 but withanother branch port added. Secondary branch 1160 accommodates localfluid delivery system 1152 for drug infusion in right renal artery 12.Tertiary branch 1164 accommodates local fluid delivery system 1154 fordrug infusion in left renal artery 14. intervention catheter 1156 entersdouble Y proximal coupler 1150 through hemostasis valve 1168.Introduction sheath 1170 is sized to accommodate local fluid deliverysystems 1152, 1154 and catheter 1156 simultaneously. FIG. 59 illustratessecondary branch 1160 and tertiary branch 1164 on the same side of thedouble proximal coupler, however they may be positioned on oppositesides or in another beneficial configuration. By way of example and notof limitation, the cross section of local fluid delivery system 1152,1154 may be oval shaped. By way of example and not of limitation, doubleY proximal coupler 1150 may be adapted to advance a wide mix of medicaldevices such as guide wires, diagnostic catheters, flow diverters andinfusion assemblies through introducer sheath 1170 and into a vascularsystem such as aorta system 10.

It is to be understood that each of the embodiments described in detailabove provide a device that can be used for selective therapeutic druginfusion as sites remote to a primary treatment site. These devices canbe applicable to interventional radiology procedures, includinginterventional diagnostic and therapeutic procedures involving thecoronary arteries. Further, each of the devices described above, can bebeneficial for delivering certain drugs, e.g., papaverine; Nifedipine;Verapamil; fenoldopam mesylate; Furosamide; Thiazide; and Dopamine; oranalogs, derivatives, combinations, or blends thereof, to the renalarteries of a patient who is simultaneously undergoing a coronaryintervention with the intent of increasing the kidney's ability toprocess of organically-bound iodine, i.e., radiographic contrast, asmeasured by serum creatinine and glomerular filtration rate (GFR).

The various embodiments herein described for the present invention canbe useful in treatments and therapies directed at the kidneys such asthe prevention of radiocontrast nephropathy (RCN) from diagnostictreatments using iodinated contrast materials. As a prophylactictreatment method for patients undergoing interventional procedures thathave been identified as being at elevated risk for developing RCN, aseries of treatment schemes have been developed based upon localtherapeutic agent delivery to the kidneys. Among the agents identifiedfor such treatment are normal saline (NS) and the vasodilatorspapaverine (PAP) and fenoldopam mesylate (FM).

The approved use for fenoldopam is for the in-hospital intravenoustreatment of hypertension when rapid, but quickly reversible, bloodpressure lowering is needed. Fenoldopam causes dose-dependent renalvasodilation at systemic doses as low as approximately 0.01 mcg/kg/minthrough approximately 0.5 mcg/kg/min IV and it increases blood flow bothto the renal cortex and to the renal medulla. Due to this physiology,fenoldopam may be utilized for protection of the kidneys from ischemicinsults such as high-risk surgical procedures and contrast nephropathy.Dosing from approximately 0.01 to approximately 3.2 mcg/kg/min isconsidered suitable for most applications of the present embodiments, orabout 0.005 to about 1.6 mcg/kg/min per renal artery (or per kidney). Asbefore, it is likely beneficial in many instances to pick a startingdose and titrate up or down as required to determine a patient's maximumtolerated systemic dose. Recent data, however, suggest that about 0.2mcg/kg/min of fenoldopam has greater efficacy than about 0.1 mcg/kg/minin preventing contrast nephropathy and this dose is preferred.

The dose level of normal saline delivered bilaterally to the renalarteries may be set empirically, or beneficially customized such that itis determined by titration. The catheter or infusion pump design mayprovide practical limitations to the amount of fluid that can bedelivered; however, it would be desired to give as much as possible, andis contemplated that levels up to about 2 liters per hour (about 25cc/kg/hr in an average about 180 lb patient) or about one liter or 12.5cc/kg per hour per kidney may be beneficial.

Local dosing of papaverine of up to about 4 mg/min through the bilateralcatheter, or up to about 2 mg/min has been demonstrated safety in animalstudies, and local renal doses to the catheter of about 2 mg/min andabout 3 mg/min have been shown to increase renal blood flow rates inhuman subjects, or about 1 mg/min to about 1.5 mg/min per artery orkidney. It is thus believed that local bilateral renal delivery ofpapaverine will help to reduce the risk of RCN in patients withpre-existing risk factors such as high baseline serum creatinine,diabetes mellitus, or other demonstration of compromised kidneyfunction.

It is also contemplated according to further embodiments that a verylow, systemic dose of papaverine may be given, either alone or inconjunction with other medical management such as for example salineloading, prior to the anticipated contrast insult. Such a dose may be onthe order for example of between about 3 to about 14 mg/hr (based onbolus indications of approximately 10-40 mg about every 3hours—papaverine is not generally dosed by weight). In an alternativeembodiment, a dosing of 2-3 mg/min or 120-180 mg/hr. Again, in thecontext of local bilateral delivery, these are considered halvedregarding the dose rates for each artery itself.

Notwithstanding the particular benefit of this dosing range for each ofthe aforementioned compounds, it is also believed that higher dosesdelivered locally would be safe. Titration is a further mechanismbelieved to provide the ability to test for tolerance to higher doses.In addition, it is contemplated that the described therapeutic doses canbe delivered alone or in conjunction with systemic treatments such asintraveneous saline.

From the foregoing discussion, it will be appreciated that the variousembodiments described herein generally provide for infusion of renalprotective drugs into each of two renal arteries perfusing both kidneysin a patient. The devices and methods of these embodiments are useful inprophylaxis or treatment of kidney malfunction or conditions, such asfor example ARF. Various drugs may be delivered via the systems andmethods described, including for example: vasodilators; vasopressors;diuretics; Calcium-channel blockers; or dopamine DA1 agonists; orcombinations or blends thereof. Further, more specific, examples ofdrugs that are contemplated in the overall systems and methods describedinclude but are not limited to: Papaverine; Nifedipine; Verapamil;Fenoldapam; Furosamide; Thiazide; and Dopamine; or analogs, derivatives,combinations, or blends thereof.

It is to be understood that the invention can be practiced in otherembodiments that may be highly beneficial and provide certainadvantages. For example radiopaque markers are shown and described abovefor use with fluoroscopy to manipulate and position the introducersheath and the intra aortic catheters. The required fluoroscopyequipment and auxiliary equipment devices are typically located in aspecialized location limiting the in vivo use of the invention to thatlocation. Other modalities for positioning intra aortic catheters arehighly beneficial to overcome limitations of fluoroscopy. For example,non fluoroscopy guided technology is highly beneficial for use inoperating rooms, intensive care units, and emergency rooms, wherefluoroscopy may not be readily available or its use may cause undueradiation exposure to users and others due to a lack of specificradiation safeguards normally present in angiography suites and thelike. The use of non-fluoroscopy positioning allows intra aorticcatheter systems and methods to be used to treat other diseases such asATN and CHF in clinical settings outside of the angiography suite orcatheter lab.

In one embodiment, the intra aortic catheter is modified to incorporatemarker bands with metals that are visible with ultrasound technology.The ultrasonic sensors are placed outside the body surface to obtain aview. In one variation, a portable, noninvasive ultrasound instrument isplaced on the surface of the body and moved around to locate the deviceand location of both renal ostia. This technology is used to view theaorta, both renal ostia and the intra aortic catheter.

In another beneficial embodiment, ultrasound sensors are placed on theintroducer sheath and the intra aortic catheter itself; specifically thetip of the aortic catheter or at a proximal section of the catheter. Theintra aorta catheter with the ultrasonic sensors implemented allows thephysician to move the sensors up and down the aorta to locate both renalostia.

A further embodiment incorporates Doppler ultrasonography with the intraaortic catheters. Doppler ultrasonography detects the direction,velocity, and turbulence of blood flow. Since the renal arteries areisolated along the aorta, the resulting velocity and turbulence is usedto locate both renal ostia. A further advantage of Dopplerultrasonography is it is non invasive and uses no x rays.

A still further embodiment incorporates optical technology with theintra aorta catheter. An optical sensor is placed at the tip of theintroducer sheath. The introducer sheath's optical sensor allowsvisualization of the area around the tip of the introducer sheath tolocate the renal ostia. In a further mode of this embodiment, atransparent balloon is positioned around the distal tip of theintroducer sheath. The balloon is inflated to allow optical visualconfirmation of renal ostium. The balloon allows for distance betweenthe tip of the introducer sheath and optic sensor while separating aortablood flow. That distance enhances the ability to visualize the imagewithin the aorta. In a further mode, the balloon is adapted to allowprofusion through the balloon wall while maintaining contact with theaorta wall. An advantage of allowing wall contact is the balloon can beinflated near the renal ostium to be visually seen with the opticsensor. In another mode, the optic sensor is placed at the distal tipsof the intra aortic catheter. Once the intra aortic catheter is deployedwithin the aorta, the optic sensor allows visual confirmation of thewalls of the aorta. The intra aortic catheter is tracked up and down theaorta until visual confirmation of the renal ostia is found. With theoptic image provided by this mode, the physician can then track thepositioning of the intra aortic catheter to the renal arteries.

Another embodiment uses sensors that measure pressure, velocity, and/orflow rate to locate renal ostia without the requirement of fluoroscopyequipment. The sensors are positioned at the distal end of the intraaortic catheter. The sensors display real time data about the pressure,velocity, and/or flow rate. With the real-time data provided, thephysician locates both renal ostia by observing the sensor data when theintra aortic catheter is around the approximate location of the renalostia. In a further mode of this embodiment, the intra aortic catheterhas multiple sensors positioned at a mid distal and a mid proximalposition on the catheter to obtain mid proximal and mid distal sensordata. From this real time data, the physician can observe a significantflow rate differential above and below the renal arteries and locate theapproximate location. With the renal arteries being the only significantsized vessels within the region, the sensors would detect significantchanges in any of the sensor parameters.

In a still further embodiment, chemical sensors are positioned on theintra aortic catheter to detect any change in blood chemistry thatindicates to the physician the location of the renal ostia. Chemicalsensors are positioned at multiple locations on the intra aorticcatheter to detect chemical change from one sensor location to another.

Although the description above contains many details, these should notbe construed as limiting the scope of the invention but as merelyproviding illustrations of some of the presently preferred embodimentsof this invention. Therefore, it will be appreciated that the scope ofthe present invention fully encompasses other embodiments which maybecome obvious to those skilled in the art, and that the scope of thepresent invention is accordingly to be limited by nothing other than theappended claims, in which reference to an element in the singular is notintended to mean “one and only one” unless explicitly so stated, butrather “one or more.” All structural, chemical, and functionalequivalents to the elements of the above-described preferred embodimentthat are known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe present claims. Moreover, it is not necessary for a device or methodto address each and every problem sought to be solved by the presentinvention, for it to be encompassed by the present claims. Furthermore,no element, component, or method step in the present disclosure isintended to be dedicated to the public regardless of whether theelement, component, or method step is explicitly recited in the claims.No claim element herein is to be construed under the provisions of 35U.S.C. 112, sixth paragraph, unless the element is expressly recitedusing the phrase “means for.”

1. A local renal infusion system for treating a renal system in apatient from a location within the abdominal aorta associated with firstand second flow paths within an outer region of abdominal aortic bloodflow generally along the abdominal aorta wall and into first and secondrenal arteries, respectively, via their corresponding first and secondrenal ostia along an abdominal aorta wall in the patient, comprising: alocal injection assembly with first and second injection ports; whereinthe local injection assembly is adapted to be positioned at the locationwith the first and second injection ports at first and second respectivepositions, respectively, corresponding with the first and second flowpaths; wherein the local injection assembly is adapted to be fluidlycoupled to a source of fluid agent externally of the patient when thelocal injection assembly is positioned at the location; and wherein thelocal injection assembly is adapted to inject a volume of fluid agentfrom the source, through the first and second injection ports at thefirst and second positions, respectively, and bi-laterally into thefirst and second renal arteries, also respectively, via the respectivecorresponding first and second renal ostia without substantiallyaltering abdominal aorta flow along the location.
 2. The system of claim1, wherein the local injection assembly is adapted to inject the volumeof fluid agent into the first and second flow paths such that theinjected volume flows substantially only into the first and second renalarteries without substantially diverting one region of aortic blood flowinto another region of aortic blood flow.
 3. The system of claim 1,wherein the local injection assembly is adapted to inject the volume offluid agent into the first and second flow paths such that the injectedvolume flows substantially only into the first and second renal arterieswithout substantially occluding abdominal aortic blood flow.
 4. Thesystem of claim 1, wherein the local injection assembly is adapted toinject the volume of fluid agent into the first and second flow pathssuch that the injected volume flows substantially only into the firstand second renal arteries without substantially isolating the first orsecond flow paths from adjacent flow paths at the location.
 5. Thesystem of claim 1, further comprising: a delivery member with a proximalend portion and a distal end portion with a longitudinal axis; whereinthe local injection assembly comprises first and second injectionmembers with first and second injection ports, respectively; wherein thelocal injection assembly is adapted to extend from the distal endportion of the delivery member and is adjustable between a firstconfiguration and a second configuration; wherein the local injectionassembly in the first configuration is adapted to be delivered by thedelivery member to the location; and wherein the local injectionassembly at the location is adjustable from the first configuration tothe second configuration such that the first and second first injectionmembers are radially extended from the longitudinal axis with the firstand second injection ports located at the first and second positions,respectively, at the first and second flow paths.
 6. The system of claim1, wherein: the local injection assembly comprises an elongate body thatis adapted to be positioned within the outer region; and the first andsecond injection ports are spaced at different locations around thecircumference of the elongate body such that the first and secondinjection ports are adapted to inject the volume of fluid agent in firstand second different respective directions laterally from the elongatebody and generally into the first and second flow paths, respectively.7. The system of claim 6, further comprising: a positioner thatcooperates with the elongate body and is adapted to position theelongate body within the outer region at the location.
 8. The system ofclaim 7, wherein: the positioner is coupled to the elongate body and isadjustable from a first configuration to a second configuration; thepositioner in the first configuration is adapted to be delivered to thelocation with the elongate body; and the positioner at the location isadapted to be adjusted from the first configuration to the secondconfiguration that is biased to radially extend from the elongate bodyrelative to the first configuration and against the abdominal aorta wallwith sufficient force so as to deflect the orientation of the elongatebody into the outer region.
 9. The system of claim 8, wherein: thepositioner comprises a partial loop-shaped member that extends withfirst and second legs from the elongate body; in the first configurationat the location the partial loop-shaped member has a first orientationwith respect to the elongate body and is adapted to be delivered to thelocation; and in the second configuration at the location the partialloop-shaped member has a second orientation that is radially extendedfrom the elongate body relative to the first orientation.
 10. The systemof claim 9, wherein: the partial loop-shaped member has a memory shape;the partial loop-shaped member is adjusted to the first configurationwhen subject to deformation force away from the memory shape; and thepartial loop-shaped member is self-adjustable from the firstconfiguration to the second configuration by material recovery of thepartial loop-shaped member from the first configuration toward thememory shape.
 11. The system of claim 10, wherein the first and secondlegs are extendable from the elongate body through first and secondextension ports, respectively; in the first configuration the first andsecond legs are withdrawn into the elongate body; and in the secondconfiguration the first and second legs are extended from the elongatebody through the first and second extension ports, respectively.
 12. Thesystem of claim 9, further comprising: a control member that is coupledto the partial loop-shaped member and also to the elongate body, andthat is adapted to adjust the looped-shape member between the first andsecond configurations by manipulating the position of the controlmember.
 13. The system of claim 9, wherein the positioner comprises aplurality of said partial loop-shaped members.
 14. The system of claim1, wherein: the local injection assembly further comprises an elongatebody with a longitudinal axis and that is adapted to be positioned atthe location; the first and second injection members in the firstconfiguration have first radial positions relative to the longitudinalaxis; and the first and second injection members in the secondconfiguration have second radial positions that are radially extendedfrom the longitudinal axis relative to the first radial position. 15.The system of claim 14, wherein: the first and second injection membersare located on opposite respective sides of the elongate body around acircumference of the elongate body.
 16. The system of claim 15, wherein:each of the first and second injection members extends between proximaland distal respective locations on each of the opposite respective sidesof the elongate body; and in the second configuration the first andsecond injection members are biased outward from the elongate bodybetween the respective proximal and distal respective locations.
 17. Thesystem of claim 16, wherein: each of the first and second injectionmembers has a length that is longer than a distance between therespective proximal and distal locations; each respective proximallocation comprises a port; each of the first and second injectionmembers in the first configuration has a proximal section that extendsproximally within the respective port at the respective proximallocation and into the elongate body; and the proximal section of each ofthe first and second injection members in the second configuration isadvanced distally through the port to extend from the elongate body. 18.The system of claim 16, wherein: each of the first and second injectionmembers adapted to be pressurized with the volume of fluid agent as itis injected through the first and second ports, respectively; and thefirst and second injection members are adapted to be adjusted from thefirst configuration to the second configuration under pressure.
 19. Thesystem of claim 16, wherein: the local injection assembly comprises agenerally loop-shaped member; the first and second injection memberscomprise first and second regions along the loop-shaped member; thefirst and second injection ports are located on each of the first andsecond regions; the loop-shaped member in the first configuration has afirst diameter between the first and second injection ports such thatthe loop-shaped member is adapted to be delivered to the location; andthe loop-shaped member in the second configuration has a second diameterbetween the first and second injection ports that is greater than thefirst diameter and is sufficient such that the first and secondpositions generally correspond with first and second flow paths withinthe outer region, respectively.
 20. The system of claim 19, wherein: thesecond configuration for the loop-shaped member comprises a memory shapefor the local injection assembly; the loop-shaped member is adjustablefrom the second configuration to the first configuration within aradially confining outer delivery sheath; the loop-shaped member isadjustable from the first configuration to the second configuration byremoving it from radial confinement outside of the outer deliverysheath.
 21. The system of claim 5, wherein: the local injection assemblycomprises a plurality of n injection members, wherein n is an integerthat is greater than two; n injection ports are located on the ninjection members, respectively; each of the n injection members isadapted to be positioned at the location such that the n injection portsare located at n unique respective positions within the outer region;wherein the local injection assembly is adapted to be oriented at thelocation such that n minus two of the plurality of injection members areoriented with the corresponding n minus two injection ports against theabdominal aorta wall, and such that the remaining two injection membersof the plurality are oriented such that the two corresponding injectionports are at the first and second positions; wherein the remaining twoinjection members are the first and second injection members; andwherein the remaining two injection ports on the two remaining injectionmembers are the first and second injection ports.
 22. The system ofclaim 21, wherein: each of the plurality of injection ports at itsrespectively unique position within the outer region is adapted to befluidly coupled simultaneously with the source of fluid agent externallyof the body; the n minus two injection ports are adapted to besubstantially prevented by the abdominal wall from injecting asubstantial volume of fluid agent from the source and into the outerregion; and the remaining two injection ports are adapted to inject asubstantial volume of fluid agent from the source and into the first andsecond renal ostia, respectively, such that local injection of fluidagent from the source is substantially isolated to the two injectionports.
 23. The system of claim 21, wherein: in the first configurationat the location the n injection members are positioned at n generallyunique radially collapsed positions around a circumference having afirst diameter around a longitudinal axis of the abdominal aorta at thelocation; and in the second configuration at the location the ninjection members are positioned at n generally unique radially expandedpositions around a circumference having a second diameter around thelongitudinal axis that is greater than the first outer diameter and thatis sufficient to position the respective n injection ports at the nrespective positions, respectively.
 24. The system of claim 21, wherein:in the first configuration at the location, each of the plurality oflocal injection members crosses another of the local injection membersat an angle relative to a longitudinal axis of the abdominal aorta atthe location; and wherein the angle changes between the first and secondconfigurations, such that the angular adjustment between crossing localinjection members allows the local injection assembly to be adjustedfrom the first configuration corresponding with the first diameter tothe second configuration corresponding with the second diameter.
 25. Thesystem of claim 5, wherein: each of the first and second injectionmembers comprises an infusion passageway with an array of n injectionregions, wherein n is an integer; each array of n injection regions isadapted to be coupled to the source of fluid agent outside the body; thefirst and second injection members are adapted to be oriented at thelocation such that x of the n respective injection regions of each arrayare positioned within the outer region and in fluid communication withthe respective renal ostium, and such that y of the respective injectionregions of each array are against the abdominal aorta wall such thatthey are substantially prevented by the abdominal aorta wall frominjecting a volume of fluid agent into the outer region; and wherein thefirst injection port comprises at least one of the x injection regionsalong the first injection member; and wherein the second injection portcomprises at least one of the x injection regions along the secondinjection member; and wherein x is a positive number that is not greaterthan n; and wherein n is equal to x plus y.
 26. The system of claim 25,wherein the n injection regions of each array are discretely locatedalong the respective injection member.
 27. The system of claim 25,wherein at least two of the n injection regions of each array arecontinuous with each other along the respective injection member. 28.The system of claim 5, further comprising: first and second markerslocated along the first and second injection members, respectively, atlocations generally corresponding with the first and second injectionports; and wherein each of the first and second markers is adapted toindicate to an operator externally of the patient the locations of thefirst and second injection ports to assist their delivery to the firstand second positions, respectively.
 29. The system of claim 28, whereinthe first and second markers comprise radiopaque markers.
 30. The systemof claim 28, wherein: the first and second injection members extenddistally from the delivery member from a bifurcation location; and aproximal marker is located at the bifurcation location.
 31. The systemof claim 5, wherein: the delivery member comprises an introducer sheathwith a proximal end portion and a distal end portion that is adapted tobe positioned at the location with the proximal end portion of theintroducer sheath extending externally from the patient, and also with adelivery passageway extending between a proximal port assembly along theproximal end portion of the introducer sheath and a distal port assemblyalong the distal end portion of the introducer sheath; the injectionassembly is adapted to be slideably engaged within the introducersheath, and is adjustable between first and second longitudinalpositions; the first and second injection members are located within thedelivery passageway in the first longitudinal position; and the firstand second injection members are extended distally through the distalport and from the distal end portion in the second longitudinalposition.
 32. The system of claim 31, wherein: the distal end portioncomprises a distal tip and a delivery marker at a location correspondingwith the distal tip such that the delivery marker is adapted to indicatethe relative position of the distal tip within the abdominal aorta atthe location.
 33. The system of claim 31, wherein: the distal portassembly comprises a single aperture through which both the first andsecond injection members extend in adjusting the injection assembly fromthe first configuration to the second configuration.
 34. The system ofclaim 33, wherein: the distal port assembly comprises first and secondports; the first delivery member is extended through the first port whenadjusted from the first configuration to the second configuration; andthe second delivery member is extended through the second port whenadjusted from the first configuration to the second configuration. 35.The system of claim 34, further comprising: a catheter body with aproximal end portion and a distal end portion that is adapted to bepositioned at the location when the proximal end portion of the catheterbody extends externally from the patient; wherein the first and secondinjection members are coupled to and extend distally from the distal endportion of the catheter body; the proximal port assembly of theintroducer sheath comprises a single proximal port; and the first andsecond injection members and distal end portion of the catheter body areadapted to be inserted into the delivery passageway through the singleproximal port.
 36. The system of claim 35, further comprising: a guidesheath that is adapted to introduce the first and second deliverymembers and distal end portion of the catheter body into the singleproximal port.
 37. The system of claim 36, wherein the guide sheath is atear-away sheath.
 38. The system of claim 1, further comprising adilator.
 39. The system of claim 1, further comprising: a proximalcoupler assembly that is adapted to be fluidly coupled to a source offluid agent externally of the patient, and also to the first and secondinjection ports at the first and second positions, respectively.
 40. Thesystem of claim 39, wherein: the proximal coupler assembly comprisesfirst and second proximal couplers; the first proximal coupler isfluidly coupled to the first injection port; and the second proximalcoupler is fluidly coupled to the second injection port.
 41. The systemof claim 40, further comprising: a first elongate body extending betweenthe first proximal coupler and the first injection member, and with afirst fluid passageway coupled to the first proximal coupler and thefirst injection port; and a second elongate body extending between thesecond proximal coupler and the second injection member, and with asecond fluid passageway coupled to the second coupler and the secondinjection port.
 42. The system of claim 39, wherein: the proximalcoupler assembly comprises a single common coupler that is fluidlycoupled to each of the first and second injection ports via a commonfluid passageway.
 43. The system of claim 42, further comprising: anelongate body extending between the single common coupler and the firstand second injection members; and wherein the elongate body has at leastone delivery passageway fluidly coupled to the single common coupler andalso to the first and second injection ports.
 44. The system of claim 1,further comprising: a source of fluid agent that is adapted to becoupled to the local injection assembly.
 45. The system of claim 44,wherein the fluid agent comprises a renal protective agent.
 46. Thesystem of claim 44, wherein the fluid agent comprises a diuretic. 47.The system of claim 46, wherein the diuretic comprises Furosemide or ananalog or derivative thereof.
 48. The system of claim 46, wherein thediuretic comprises Thiazide or an analog or derivative thereof.
 49. Thesystem of claim 44, wherein the fluid agent comprises a vasopressor. 50.The system of claim 49, wherein the vasopressor comprises Dopamine or ananalog or derivative thereof.
 51. The system of claim 44, wherein thefluid agent comprises a vasodilator.
 52. The system of claim 44, whereinthe fluid agent comprises a vasoactive agent.
 53. The system of claim44, wherein the fluid agent comprises Papaverine or an analog orderivative thereof.
 54. The system of claim 44, wherein the fluid agentcomprises a Calcium-channel blocker.
 55. The system of claim 44, whereinthe fluid agent comprises Nifedipine or an analog or derivative thereof.56. The system of claim 44, wherein the fluid agent comprises Verapamilor an analog or derivative thereof.
 57. The system of claim 44, whereinthe fluid agent comprises fenoldapam mesylate or an analog or derivativethereof.
 58. The system of claim 44, wherein the fluid agent comprises adopamine DA1 agonist.
 59. The system of claim 1, further comprising: avascular access system with an elongate tubular body with at least onelumen extending between a proximal port assembly and a distal port thatis adapted to be positioned within a vessel having translumenal accessto the location; a percutaneous translumenal interventional device thatis adapted to be delivered to an intervention location across thelocation while the local injection assembly is at the location; andwherein the local injection assembly and percutaneous translumenalinterventional device are adapted to be delivered percutaneously to thelocation and intervention location, respectively, through the vascularaccess device, and are also adapted to be simultaneously engaged withinthe vascular access device.
 60. The system of claim 59, wherein thepercutaneous translumenal interventional device comprises anangiographic catheter.
 61. The system of claim 59, wherein thepercutaneous translumenal interventional device comprises a guidingcatheter.
 62. The system of claim 59, wherein the percutaneoustranslumenal interventional device is between about 4 French and about 8French.
 63. The system of claim 59, wherein: the proximal port assemblycomprises first and second proximal ports; the percutaneous translumenalinterventional device is adapted to be inserted into the elongate bodythrough the first proximal port; and the first and second ports of theinjection assembly are adapted to be inserted into the elongate bodythrough the second proximal port.
 64. The system of claim 1, wherein:the volume of fluid agent comprises a first volume; the local injectionassembly comprises a fluid reservoir; the first injection port isfluidly coupled to the fluid reservoir; the fluid reservoir isadjustable between a first condition, a second condition, and a thirdcondition; in the first condition the fluid reservoir is adapted to bedelivered to the location with the first injection port at the firstposition at the location; the fluid reservoir at the location is adaptedto be fluidly coupled to a source of fluid agent located externally ofthe patient; the fluid reservoir at the location is adjustable from thefirst condition to the second condition such that the first volume fromthe source is delivered into the fluid reservoir; and the localinjection assembly at the location is further adjustable from the secondcondition to the third condition wherein the fluid reservoir dischargesthe first volume of fluid agent through the injection port at theposition; and wherein the injected first volume of fluid agent isadapted to flow principally into the first flow path.
 65. The system ofclaim 64, wherein: the reservoir comprises an adjustable wall that formsa chamber; the first injection port is located on the chamber; theadjustable wall is adjustable between first and second shapes; in thefirst shape the adjustable wall is radially collapsed such that thechamber has a first diameter; in the second shape the adjustable wall isradially expanded relative to the first shape such that the chamber hasa second diameter adapted to house the first volume of fluid agent; thefirst shape generally corresponds with the first and third conditions;and the second shape generally corresponds with the second condition.66. The system of claim 65, wherein: the first shape is a memory shapefor the adjustable wall; the adjustable wall is adjusted from the firstshape to the second shape by inflation pressure from the first volume offluid agent injected into the reservoir in the second condition; and theadjustable wall is self-adjustable from the second shape to the firstshape with a memory recovery force upon removal of the inflationpressure; and the memory recovery force is sufficient to inject thefirst volume of fluid agent from the reservoir and through the injectionport into the first position within the first flow path.
 67. The systemof claim 65, wherein: the reservoir comprises a wall that forms at leastin part a chamber; the first injection port is located on the chamber ata first location; a flow port is located on the chamber at a secondlocation and is fluidly coupled with the first injection port via thechamber; the flow port is adapted to allow systolic abdominal aorticblood flow to flow into the flow port, through the chamber, and out thefirst injection port; the flow port is adapted to substantially preventdiastolic abdominal aortic blood flow from flowing through the chamber;the fluid reservoir is adjustable from the first condition to the secondcondition during diastolic abdominal aortic blood flow; and transitionfrom diastolic to systolic abdominal aortic blood flow adjusts the fluidreservoir from the second condition to the third condition.
 68. Thesystem of claim 64, wherein: the fluid reservoir comprises a first fluidreservoir; the volume of fluid agent comprises a first volume of fluidagent and a second volume of fluid agent; the second injection membercomprises a second fluid reservoir; the second fluid reservoir at thelocation is adapted to be fluidly coupled to a source of fluid agentlocated externally of the patient; in the second condition the secondvolume of fluid agent from the source is delivered into the second fluidreservoir; and in the third condition wherein the second fluid reservoirdischarges the second volume of fluid agent through the injection portat the position.